EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 11500A |
Device Problem
Central Regurgitation (4068)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/28/2024 |
Event Type
Injury
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Manufacturer Narrative
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H10: additional narratives: surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.The device was not returned for evaluation, as it remains implanted.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
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Event Description
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It was reported that a 23mm pericardial aortic valve was disabled via a valve-in-valve procedure after an implant duration of 4 years, 10 months due to central regurgitation.A 26mm transcatheter valve was implanted successfully.
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Manufacturer Narrative
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H11.Additional narrative updated d4, h4, and h6 per new information received a definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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Search Alerts/Recalls
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