Model Number 3300TFX |
Device Problems
Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457); Detachment of Device or Device Component (2907); Insufficient Information (3190)
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Patient Problems
Chest Pain (1776); Fall (1848); Insufficient Information (4580)
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Event Date 08/18/2023 |
Event Type
Injury
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Event Description
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It was learned via implant patient registry that a 25mm aortic valve was explanted and replaced with a 27mm valve after an implant duration of 2 years, 9 months due to unknown reasons.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.
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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 device request is ongoing.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 learned via implant patient registry that a 25mm aortic valve was explanted and replaced with a 27mm valve after an implant duration of 2 years, 9 months due to dehiscence, perivalvular leak, severe regurgitation, and moderate stenosis.The patient presented with chest pain and falling.Per medical records the alleged valve exhibited rocking motion.There appeared to be an old infection and completely disconnected from the annulus at the left and non commissure.The root appeared to have a healed previous infection.Upon coming off bypass there appeared to be a very small perivalvular leak.The surgeon went back on bypass and placed 2 pledgeted stitches in the area that showed a leak.No leaks were identified afterwards.The patient was discharged on pod #4.
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Manufacturer Narrative
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H10: additional narratives: updated b5, b7, and h6 per new information received.
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Manufacturer Narrative
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H10: additional narratives: updated d4, h4, and h6 per new information received.The most likely cause is patient factors, including hyperlipidemia (hld) and diabetes mellitus (dm).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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