Model Number 11500A |
Device Problems
Detachment of Device or Device Component (2907); Central Regurgitation (4068)
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Patient Problems
Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)
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Event Date 02/01/2024 |
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 aortic valve was disabled via a valve-in-valve procedure after an implant duration of 5 months due to severe insufficiency, perivalvular leak, and dehiscence.The patient presented with nyha class 3 hfpef and dyspnea.A 23mm transcatheter valve was implanted successfully.Subsequent tee interrogation revealed good placement of the valve without significant stenosis.The aortic insufficiency now was completely gone.
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Manufacturer Narrative
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A definitive root cause cannot be conclusively determined; however, patient and/or procedural 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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