On-X Heart Prosthetic Heart Valve IFU Rev N

Transcription

On-X Prosthetic Heart ValveInstructions for UseEnglishOn-X Aortic Heart Valve with Standard Sewing Ring - REF ONXAOn-X Mitral Heart Valve with Standard Sewing Ring - REF ONXMOn-X Aortic Heart Valve with Conform-X Sewing Ring - REF ONXACOn-X Mitral Heart Valve with Conform-X Sewing Ring - REF ONXMCOn-X Aortic Heart Valve with Anatomic Sewing Ring - REF ONXANOn-X Aortic Heart Valve and Extended Holder - REF ONXAEOn-X Aortic Heart Valve with Conform-X Sewing Ring and Extended Holder - REF ONXACEOn-X Aortic Heart Valve with Anatomic Sewing Ring and Extended Holder - REF ONXANE0459

EnglishON-X PROSTHETICHEART VALVEINSTRUCTIONS FOR USEOn-X Aortic Heart Valve withStandard Sewing RingOn-X Mitral Heart Valve withStandard Sewing RingOn-X Aortic Heart Valve withConform-X Sewing RingOn-X Mitral Heart Valve withConform-X Sewing RingOn-X Aortic Heart Valve withAnatomic Sewing RingOn-X Aortic Heart Valve andExtended HolderOn-X Aortic Heart Valve withConform-X Sewing Ring andExtended HolderOn-X Aortic Heart Valve withAnatomic Sewing Ring andExtended HolderFor more information visitwww.onxlti.com/ifuTABLE OF CONTENTSON-X PROSTHETIC HEART VALVE. 2INSTRUCTION FOR USE. 41. DEVICE DESCRIPTION . 42. INDICATIONS FOR USE . 43. CONTRAINDICATIONS. 44. WARNINGS AND PRECAUTIONS. 54.1 WARNINGS. 54.2 PRECAUTIONS. 55. POTENTIAL ADVERSE EVENTS. 56. INDIVIDUALIZATION OF TREATMENT. 56.1 SPECIFIC PATIENT POPULATION. 57. PATIENT COUNSELING. 58. HOW SUPPLIED . 68.1 AVAILABLE MODELS AND SIZES. 68.2 PACKAGING. 68.3 STORAGE. 68.4 ACCESSORIES. 78.5 ACCESSORY CLEANING AND STERILIZATION. 89. DIRECTIONS FOR USE. 89.1 PHYSICIAN TRAINING. 89.2 STERILIZATION AND RESTERILIZATION. 89.3 HANDLING AND PREPARATION INSTRUCTIONS . 89.4 DEVICE IMPLANTATION .109.5 SUTURING TECHNIQUES.109.6 LEAFLET MOTION ASSESSMENT AND VALVE ROTATION.119.7 VALVE ORIENTATION.1210. POSTOPERATIVE INFORMATION. 1210.1 MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY.1210.2 RETURNED GOODS.1211. PATIENT INFORMATION. 1211.1 PATIENT REGISTRATION.1211.2 PATIENT RECORD CARD.1311.3 PATIENT INFORMATION BOOKLET.1312. DISCLAIMER OF WARRANTIES. 13APPENDIX A . 131. ADVERSE EVENTS. 131.1 OBSERVED ADVERSE EVENTS.132. CLINICAL STUDIES . 13On-X Prosthetic Heart Valve Instructions for Use2

EnglishLIST OF FIGURESFigure 1: Aortic and Mitral Profiles. 4Figure 2: Standard or Extended Aortic Valve Holders . 6Figure 3a: Sizer and Replica Sizer. 7Figure 3b: Sizer . 7Figure 4: Instrument Handle . 8Figure 5: Rotator. 8Figure 6: Leaflet Probe . 8Figure 7a. Twist-off outer lid . 9Figure 7b. Remove by pull tab. . 9Figure 7c. .or invert on sterile field. 9Figure 8a. Peel-off outer lid. 9Figure 8b. Remove by pull tab. 9Figure 8c. .or invert on sterile field. 9Figure 9. Opening the inner container.10Figure 10. Inserting the instrument handle.10Figure 11. Aortic replica sizers verify the aortic valve.10Figure 12. Supra-annular valve positioning .11Figure 13. Sewing ring cross-sections.11Figure 14. Removing the valve holder.11Figure 15. Insert valve rotator .12Figure 16. Pivot axis of the mitral valve positioned anti-anatomically.12LIST OF CHARTSChart 1: Patient Follow-up Over Time.15LIST OF TABLESTable 1: On-X Valve Specifications (millimeters). 6Table 2: Sizer Selections - Regardless of Aortic Holder Type. 7Table 3: Aortic Replacement Observed Adverse Event Rates.15Table 4: Mitral Replacement Observed Adverse Event Rates.16Table 5: Preoperative Patient Demographics.16Table 6: Operative Patient Demographics.17Table 7: Number Implanted and Years by Valve Size.18Table 8: Valve Effectiveness Outcomes.18Table 9: Effectiveness Outcomes, Hemodynamic Results.19On-X Prosthetic Heart Valve Instructions for Use3

EnglishINSTRUCTION FOR USECAUTION: Federal law (USA) restricts this device tosale by or on the order of a physician.Figure 1: Aortic and Mitral Profiles(See Table 1 for corresponding dimensions)(A) AORTIC (ONXA, ONXAE)1. DEVICE DESCRIPTIONThe On-X Prosthetic Heart Valve (Figure 1) is a bileafletmechanical heart valve, which consists of an orificehousing and two leaflets. The orifice inflow area has aflared inlet designed to reduce flow turbulence, andthe outflow rim consists of leaflet guards designed toprotect the leaflets while in the closed position. Theleaflets rotate around tabs located within the innercircumference of the orifice ring. In the closed position,each leaflet forms a nominal angle of 40º relative to theplane of the orifice. In the open position, the plane ofeach leaflet forms a nominal angle of 90º relative to theplane of the orifice. The leaflets have a travel arc of 50ºto the closed position.The orifice is composed of graphite substrate coatedwith On-X Carbon, a pure unalloyed form of pyrolyticcarbon. The leaflets consist of On-X Carbon depositedon a graphite substrate, which is impregnated with 10weight% tungsten to provide radiopacity.The sewing ring is constructed ofpolytetrafluoroethylene (PTFE) fabric mounted on theorifice using titanium retaining rings and 5-0 suturematerial. This form of sewing ring attachment to theorifice allows for rotation of the sewing ring in situ duringimplantation. Orientation reference marks are providedon the sewing ring for valve orientation.The On-X Prosthetic Heart Valve is available in 3aortic and 2 mitral sewing ring configurations. Allaortic configurations are available in sizes 19, 21, 23,25, and 27/29 mm. The standard mitral sewing ring isavailable in sizes 23, 25, 27/29 and 31/33, while the mitralConform-X sewing ring is available in size 25/33 only.Aortic valves, size 19 mm through 25 mm, are designedfor intrasupra-annular sewing ring position, while thevalve size 27/29 mm is designed for intra-annular sewingring position. All mitral valve sizes are designed for thesupra-annular sewing ring position.2. INDICATIONS FOR USEThe On-X Prosthetic Heart Valve is indicated for thereplacement of diseased, damaged, or malfunctioningnative or prosthetic heart valves in the aortic and mitralpositions.3. CONTRAINDICATIONSThe On-X Prosthetic Heart Valve is contraindicated forpatients unable to tolerate anticoagulation therapy.orifice internal diameter (D)tissue annulus (mounting) diameter (A)external sewing ring diameter (S)profile height open (H)profile height closed (h)(B) AORTIC CONFORM-X (ONXAC, ONXACE)orifice internal diameter (D)tissue annulus (mounting) diameter (A)external sewing ring diameter (S)profile height closed (h)profile height open (H)(C) AORTIC ANATOMIC (ONXAN, ONXANE)orifice internal diameter (D)tissue annulus (mounting) diameter (A)external sewing ring diameter (S)profile height closed (h)profile height open (H)(D) MITRAL (ONXM)external sewing ring diameter (S)orifice internal diameter (D)tissue annulus (mounting) diameter (A)profile height open (H)profile height closed (h)(E) MITRAL CONFORM-X (ONXMC)external sewing ring diameter (S)orifice internal diameter (D)tissue annulus (mounting) diameter (A)profile height open (H)profile height closed (h)On-X Prosthetic Heart Valve Instructions for Use4

English4. WARNINGS AND PRECAUTIONS4.1 WarningsFOR SINGLE USE ONLY.DO NOT use the On-X Prosthetic Heart Valve if: the prosthesis has been dropped, damaged, ormishandled in any way; the expiration date has elapsed; the tamper evident seal is broken; the serial number tag does not match the serialnumber on the container label.DO NOT pass a catheter, surgical instrument, ortransvenous pacing lead through the prosthesis asthis may cause valvular insufficiency, leaflet damage,leaflet dislodgment, and/or catheter/instrument/leadentrapment.DO NOT resterilize the On-X Prosthetic Heart Valve.4.2 PrecautionsHandle the prosthesis with only On-X LifeTechnologies, Inc. (On-XLTI) On-X Prosthetic HeartValve Instruments. Only On-XLTI On-X ProstheticHeart Valve sizers should be used during theselection of the valve size; other sizers may result inimproper valve selection. prosthesis thrombosis stroke thromboembolismIt is possible that these complications could lead to: reoperationexplantationpermanent disabilitydeathMechanical prosthetic heart valves produce audiblesounds as a normal function of their operation. In somepatients, these sounds may be objectionable.Risk of Re-Use StatementIn accordance with the EU Medical Device Directive,93/42/EEC, Annex I, Section 13.6h, the devicemanufacturer must provide information on risksassociated with re-use of a single use device. Therefore,the following statement is provided:The implanted On-X prosthetic heart valve is designedfor single use only. Do not re-use the device. In additionto the risks listed in Section 5, re-use may causeprocedural complications including device damage,compromised device biocompatibility, and devicecontamination. Re-use may result in infection, seriousinjury, or patient death.Avoid contacting the carbon surfaces of the valvewith gloved fingers or any metallic or abrasiveinstruments as they may cause damage to the valvesurface not seen with the unaided eye that may leadto accelerated valve structural dysfunction, leafletescape, or serve as a nidus for thrombus formation.6. INDIVIDUALIZATION OF TREATMENTAdequate anticoagulant or anticoagulant/antiplatelettherapy should be administered. Selection of ananticoagulant or anticoagulant/antiplatelet regimen isbased on the particular needs of the patient and theclinical situation.Avoid damaging the prosthesis through theapplication of excessive force to the valve orifice orleaflets.6.1 Specific Patient PopulationThe safety and effectiveness of the On-X ProstheticHeart Valve has not been established for the followingspecific populations because it has not been studied inthese populations:5. POTENTIAL ADVERSE EVENTSAdverse events potentially associated with the use ofprosthetic heart valves (in alphabetical order) include,but are not limited to: anginacardiac arrhythmiaendocarditisheart failurehemolysishemolytic anemiahemorrhagemyocardial infarctionprosthesis leaflet entrapment (impingement)prosthesis nonstructural dysfunctionprosthesis pannusprosthesis perivalvular leakprosthesis regurgitationprosthesis structural dysfunctionOn-X Prosthetic Heart Valve Instructions for Use patients who are pregnant;nursing mothers;patients with chronic endocarditis;patients requiring pulmonary or tricuspidreplacement.7. PATIENT COUNSELING Prophylactic antibiotic treatment must be providedto all patients with prosthetic valves undergoingdental procedures or other potentially bacteremicprocedures. Patients require anticoagulation or anticoagulant/antiplatelet therapy. Patients should be encouraged to complete thePatient ID card provided with the valve and carry itwith them at all times.5

English8. HOW SUPPLIED8.1 Available Models and SizesThe On-X Prosthetic Heart Valve is available in 3 aorticand 2 mitral sewing ring configurations. All aorticconfigurations are available in sizes 19, 21, 23, 25, and27/29 mm. The standard mitral sewing ring is availablein sizes 23, 25, 27/29 and 31/33 mm, while the MitralConform-X sewing ring is available in size 25/33 only.Aortic valves, size 19 mm through 25 mm, are designedfor intrasupra-annular sewing ring position, while thevalve size 27/29 mm is designed for intra-annular sewingring position. All mitral valve sizes are designed for thesupra-annular sewing ring position.Aortic valves are available with either standard orextended valve holders (Figure 2).Figure 2: Standard or Extended Aortic Valve HoldersExtended HolderStandard HolderThe dimensional and model specifications for allavailable sizes of the On-X Prosthetic Heart Valve areshown in Table 1 and Figure 1. The symbol SZ mm onthe box, container labels, and implant registration cardrefers to the tissue annulus diameter of the valve inmillimeters.8.2 PackagingThe On-X Prosthetic Heart Valve is provided sterile,mounted on a holder, in a double-sealed plasticcontainer. The package consists of the following items: Outer boxPatient record cardPlastic valve containerImplant registration cardPlastic valve holderValve serial number tagInstructions for useInstruments for implantation of the On-X ProstheticHeart Valve are supplied separately, NON-STERILE, andmust be cleaned and sterilized prior to use as outlined insection 8.5.8.3 StorageThe On-X Prosthetic Heart Valve has been qualifiedfor a maximum storage life of 5 years from the date ofmanufacture for the twist-off lid design, or 6 years forthe peel-off lid design. The sterility expiration date ofthe On-X Prosthetic Heart Valve is recorded on the outerpackage label. Appropriate inventory control should bemaintained so that prostheses with earlier expirationdates are preferentially implanted and expiration isavoided. To protect the valve, it should be stored in itsouter box until used. The storage environment shouldbe clean, cool, and dry.Table 1: On-X Valve Specifications (millimeters)Model DesignatorExtended HolderStandard HolderSize/TypeTissue Annulus(mounting)Diameter(A)Orifice InternalDiameter(D)ExternalSewing RingDiameter(S)Profile Height(closed)(h)Profile Height(open)(H)Internal OrificeArea(mm²)ONXAE-19*ONXA-1919 Aortic1917.42310.813.3228ONXAE-21*ONXA-2121 Aortic2119.42611.914.7284344ONXAE-23*ONXA-2323 Aortic2321.42913.116.1ONXAE-25*ONXA-2525 29 Aortic27-2923.43414.217.8411ONXACE-19*ONXAC-19*19 Aortic Conform-X1917.42710.813.3228ONXACE-21*ONXAC-21*21 Aortic Conform-X2119.43011.914.7284ONXACE-23*ONXAC-23*23 Aortic Conform-X2321.43313.116.1344ONXACE-25*ONXAC-25*25 Aortic 29*27/29 Aortic 19 Aortic Anatomic1917.42710.813.3228ONXANE-21*ONXAN-21*21 Aortic Anatomic2119.43011.914.7284ONXANE-23*ONXAN-23*23 Aortic Anatomic2321.43313.116.1344ONXANE-25*ONXAN-25*25 Aortic 9*27/29 Aortic Anatomic27/2923.43614.217.8411344ONXM-23**23 Mitral2321.43113.116.1ONXM-2525 Mitral2523.43314.217.8411ONXM-27/2927/29 Mitral27-2923.43414.217.8411ONXM-31/3331/33 Mitral31-3323.43614.217.8411ONXMC-25/33Mitral Conform-X25-3323.43914.217.8411* Not available in all markets** Not available in the USAOn-X Prosthetic Heart Valve Instructions for UseRefer to Figure 1 for location of measured dimensions. Values given are nominal within the tolerance band.6

English8.4 AccessoriesThe On-X Prosthetic Heart Valve is designed to be usedonly with On-XLTI On-X instruments. The instruments,supplied separately, are provided as a set, whichincludes sizers, rotators, an instrument handle, and aleaflet probe. The instruments are reusable.CAUTION: Sizers and instrument handles havemetallic regions that are bendable. Repeatedbending of these metallic regions can lead to fatigueand fracture. To avoid instrument fracture duringuse, the stem should be inspected for surfacecracks before and after each time it is bent. If metalfatigue surface cracks are present, the sizer and/or instrument handle should be discarded andreplaced. Contact On-XLTI Customer Service to orderreplacements.Replica SizersAortic replica sizers are provided for all aortic valvesizes (Figure 3a). They model the On-X standard aorticvalve profile. They are used after sizing for standard,Conform-X, and Anatomic sewing ring configurationsto assure fit of the aortic valve without obstruction ofthe coronary arteries. The size 19 through 25 aorticreplica sizers shape is intended to model intrasupraannular positioning. The size 27/29 aortic replica sizer isintended to model intra-annular positioning.Figure 3a: Sizer and Replica SizerCylindricalCAUTION: Leaflet probes and rotators are flexible,but are not intended to be bent to a permanentlydeformed state.Aortic ReplicaSizerThe sizer is used to gauge the resulting tissue annulusdiameter after the annulus is prepared for implant. Thesizer has a bendable stem on each end. The sizers arecylindrical for size 19 mm through 25 mm valves andconical for size 27/29 mm and 31/33 mm valves (Figure 3aand 3b

0459 Prosthetic Heart Valve Instructions for Use English On-X Aortic Heart Valve with Standard Sewing Ring - REF ONXA On-X Mitral Heart Valve with Standard Sewing Ring - REF ONXM On-X Aortic Heart Valve with Conform-X Sewing Ring - REF ONXAC On-X Mitral Heart Valve with Conform-X Sewing Ring - REF ONXMC On-X