Model Number 2700TFX |
Device Problems
Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457)
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Patient Problem
Heart Failure/Congestive Heart Failure (4446)
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Event Date 04/07/2023 |
Event Type
Injury
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Manufacturer Narrative
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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 27mm aortic valve underwent a valve-in-valve procedure after an implant duration of 9 years, 3 months due to stenosis, moderate insufficiency, and mild perivalvular leak.The patient presented with hf.The procedure was performed with a 29mm transcatheter valve.The patient was stable throughout the procedure and valve was implanted successfully.
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Manufacturer Narrative
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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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