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  • Occluder Device Fatigue Testing · paper focuses on pulsatile and axial fatigue testing ... accelerated to obtain results in a shorter time ... derived from customer-provided FEA
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5929 Baker Road, Suite 430 · Minnetonka, MN 55345 · P: 952.933.1152 · F: 952.933.1186 · E: [email protected] Occluder Device Fatigue Testing Structural heart occluders and closure devices are used to treat congenital heart defects such as atrial septal defect, ventricular septal defect, patent ductus arteriosus and patent foramen ovale. While there are no specific standards for occluder device testing, many of the cardiovascular implant standards such as ISO 5840-1 (2015) cover aspects of occluder testing. Executive summary documents on the US FDA website (www.fda.gov) from occluder manufacturers for products such as the AMPLATZER™ Patent Foramen Ovale Occluder from St. Jude Medical (now Abbott) and GORE HELEX™ Septal Occluder from W.L. Gore & Associates, Inc., might also be helpful in identifying relevant bench testing. Test examples listed in these documents include: fatigue testing, tensile strength, stress relaxation, finished device pressure, nickel leachability, particulate testing, and corrosion testing. While our lab offers particulate testing, nickel leachability, corrosion testing, and other occluder tests, this paper focuses on pulsatile and axial fatigue testing protocols. Pulsatile Fatigue Element Minnetonka excels at pulsatile fatigue testing of cardiovascular medical devices and has developed specialized fixtures for occluders and other closure devices. The image on the right shows a stent graft tester configured to accommodate ventricular septal occluder devices with a custom-designed fixture that specifically loads the neck/stem of the device. Devices in the test shown were subject to pulsatile radial fatigue for 100M cycles to simulate 2.5 years of implantation; typical tests range from 40M to 600M cycles. A frequency sweep is conducted prior to the testing to determine a stable and safe testing frequency to minimize potential artifacts (i.e., diametric excursions) observed using laser micrometer, strobe light, or high speed video camera. The test is accelerated to obtain results in a shorter time-period than physiological rates would allow and is conducted under simulated physiological environment, in saline at 37 ± 2°C. Devices were tested to meet the requirements of the FDA Recognized Consensus Standard ASTM F 2477 and FDA Guidance 1545 (2010): Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Devices and Associated Delivery Systems. The image on the left shows a stent graft tester configured to accommodate two closure devices per station with specialized mounting requirements. The objective of this test is to demonstrate device integrity under mechanical fatigue for 400M cycles to meet the requirements for in vitro mechanical fatigue testing stated in ASTM F 2477 and ISO 25539-1 AMENDMENT 1. Target strain is derived from customer-provided FEA analysis based on worst-case clinical loading conditions.

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Page 1: Occluder Device Fatigue Testing · paper focuses on pulsatile and axial fatigue testing ... accelerated to obtain results in a shorter time ... derived from customer-provided FEA

5929BakerRoad,Suite430·Minnetonka,MN55345·P:952.933.1152·F:952.933.1186·E:[email protected]

OccluderDeviceFatigueTestingStructuralheartoccludersandclosuredevicesareusedtotreatcongenitalheartdefectssuchasatrialseptaldefect,ventricularseptaldefect,patentductusarteriosusandpatentforamenovale.Whiletherearenospecificstandardsforoccluderdevicetesting,manyofthecardiovascularimplantstandardssuchasISO5840-1(2015)coveraspectsofoccludertesting.ExecutivesummarydocumentsontheUSFDAwebsite(www.fda.gov)fromoccludermanufacturersforproductssuchastheAMPLATZER™PatentForamenOvaleOccluderfromSt.JudeMedical(nowAbbott)andGOREHELEX™SeptalOccluderfromW.L.Gore&Associates,Inc.,mightalsobehelpfulinidentifyingrelevantbenchtesting.Testexampleslistedinthesedocumentsinclude:fatiguetesting,tensilestrength,stressrelaxation,finisheddevicepressure,nickelleachability,particulatetesting,andcorrosiontesting.Whileourlaboffersparticulatetesting,nickelleachability,corrosiontesting,andotheroccludertests,thispaperfocusesonpulsatileandaxialfatiguetestingprotocols.PulsatileFatigue ElementMinnetonkaexcelsatpulsatilefatiguetestingofcardiovascularmedicaldevicesandhasdevelopedspecializedfixturesforoccludersandotherclosuredevices.Theimageontherightshowsastentgrafttesterconfiguredtoaccommodateventricularseptaloccluderdeviceswithacustom-designedfixturethatspecificallyloadstheneck/stemofthedevice.Devicesinthetestshownweresubjecttopulsatileradialfatiguefor100Mcyclestosimulate2.5yearsofimplantation;typicaltestsrangefrom40Mto600Mcycles.Afrequencysweepisconductedpriortothetestingtodetermineastableandsafetestingfrequencytominimizepotentialartifacts(i.e.,diametricexcursions)observedusinglasermicrometer,strobelight,orhighspeedvideocamera.Thetestisacceleratedtoobtainresultsinashortertime-periodthanphysiologicalrateswouldallowandisconductedundersimulatedphysiologicalenvironment,insalineat37±2°C. DevicesweretestedtomeettherequirementsoftheFDARecognizedConsensusStandardASTMF2477andFDAGuidance1545(2010):Non-ClinicalEngineeringTestsandRecommendedLabelingforIntravascularDevicesandAssociatedDeliverySystems.

Theimageontheleftshowsastentgrafttesterconfiguredtoaccommodatetwoclosuredevicesperstationwithspecializedmountingrequirements.Theobjectiveofthistestistodemonstratedeviceintegrityundermechanicalfatiguefor400McyclestomeettherequirementsforinvitromechanicalfatiguetestingstatedinASTMF2477andISO25539-1AMENDMENT1.Targetstrainisderivedfromcustomer-providedFEAanalysisbasedonworst-caseclinicalloadingconditions.

Page 2: Occluder Device Fatigue Testing · paper focuses on pulsatile and axial fatigue testing ... accelerated to obtain results in a shorter time ... derived from customer-provided FEA

5929BakerRoad,Suite430·Minnetonka,MN55345·P:952.933.1152·F:952.933.1186·E:[email protected]

AxialFatigue Thetwoimagesbelowareexamplesofcustom-designedfixturesforoccluderandclosuredevicetensilefatiguetesting.Theyarebothmulti-specimenfixturesandcanaccommodatedevicesofdifferentdiameters.Insomecases,oneortwowedgesareplacedbetweentheplatestosimulateworst-casescenarioswhereoneorbothdiscsareatananglewithrespecttothestem.

Theimageontherightshowsamulti-specimenbendingfatiguefixturedesignedforpatentforamenovaleclosuredevices.Akeyadvantageofthedesignisthatitallowsbothpositiveandnegativebendingthroughaninflectionpointforeitherunidirectionalorbidirectionalbendingfatiguetests.Customer-providedFEAdataareusedtodefinethedesiredangulardisplacements,andtestingcantypicallybeacceleratedupto40Hz.Inspections Inspectionsareakeycomponentofanywell-designedtestprotocol.Devicesaretypicallyinspectedpriortotesting,duringthetestatpre-determinedintervalsandpost-testing.Duetothebraideddesignofmanyoftheoccluderandclosuredevices,itisimportanttolookforsignsoffrettingcorrosionthatmayoccurparticularlyinregionsofdisctostemoverlappingmaterial.AdditionalTestingFatiguetestingisonetypeofrelevantbenchtestingforoccludersandclosuredevices.Corrosiontesting,particulatetesting,nickelleachabilityandothermechanicaltestsmayalsoberequireddependingonyourdevice.Ifyouwouldlikeassistancewithyourdevice’sbenchtesting,pleasefilloutourtestquestionnaireorcallusat952-933-1152todiscusshowwecanhelp. ElementMaterialsTechnologyoffersthebroadestscopeofmedicaldevicetesting,soifyouarelookingforservicessuchaspackagetesting,microbiologicaltesting,acceleratedshelflifetestingorEMC/EMItesting,contactustoconnectwiththerightlab.


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