EDWARDS LIFESCIENCES LLC KONECT RESILIA AORTIC VALVED CONDUIT AVC; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 11060A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/08/2024 |
Event Type
Injury
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Manufacturer Narrative
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H10: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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Event Description
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It was learned through implant patient registry that a 25mm 11060a aortic valved conduit, in aortic position was explanted and replaced with another 25mm 11060a aortic valve after an implant duration of one (1) year, 3 months, and 14 days due to unknown reasons.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.
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Manufacturer Narrative
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H11: additional manufacturer narrative: updated sections: b4, g3, g6, h2, h6 (investigation findings, and investigation conclusions).A device history record (dhr) review was not performed, as no information regarding a device failure mode was provided.Furthermore, there is no allegation of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.Engineering evaluation summary: an engineering evaluation is not required because there is no allegation of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.An ifu review is unable to be performed, as no details regarding failure mode of the device were provided.A capa/scar/pra is not required as there is no confirmed product, or labeling non-conformances and no other triggers are met.Based on the information available, a definitive root cause cannot be conclusively determined.All pertinent information available to edwards lifesciences has been submitted.
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