EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 11500A |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/04/2023 |
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 patient with a 25mm aortic valve is being evaluated for a valve-in-valve procedure on pod #8 due to leaflet tear.As reported the patient is having impella device and in icu.
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Manufacturer Narrative
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H10: additional narratives: updated d4, h4, and h6 per new information received.A root cause of the failure of valve requiring an evaluation for valve-in-valve procedure could not be determined, however procedural factors including the use of the impella device could have 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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