EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 8300AB |
Device Problems
Calcified (1077); Gradient Increase (1270)
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Patient Problems
Dyspnea (1816); Swelling/ Edema (4577)
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Event Date 10/03/2023 |
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 25mm aortic valve is being evaluated for a valve-in-valve procedure after an implant duration of 6 years, 7 months due to calcification and stenosis.The patient presented with doe and edema.
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Manufacturer Narrative
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H10: additional narratives: 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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