EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 11500A |
Device Problems
Degraded (1153); Insufficient Information (3190)
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Patient Problems
Dyspnea (1816); Fatigue (1849); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
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Event Date 03/07/2024 |
Event Type
Injury
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Manufacturer Narrative
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H11: 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 27mm aortic valve is being evaluated for a valve-in-valve procedure after an implant duration of 3 years, 6 months due to stenosis.
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Event Description
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It was reported that a patient with a 11500a 27mm aortic valve is being evaluated for a valve-in-valve procedure after an implant duration of 3 years, 6 months due to severe stenosis, mild regurgitation, leaflet immobility/restriction, and deterioration.The patient presented with acute on chronic chf, doe, fatigue, and orthopnea.
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Manufacturer Narrative
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The most likely cause is patient factors, including chronic kidney disease (ckd), peripheral vascular disease (pvd) and native bicuspid aortic valve (bav).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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