Model Number 8300AB |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/14/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device was explanted > 0 days for unknown reasons.Although there are multiple root causes, valves are typically explanted because they are not functioning optimally.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 from implant patient registry that a 27mm aortic valve was explanted and replaced with a 27mm valve after an implant duration of 5 years, 2 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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Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
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Event Description
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It was learned from implant patient registry that a 8300ab 27mm aortic valve was explanted and replaced with a 11500a 27mm after an implant duration of 5 years, 2 months due to streptococcus sanguinis endocarditis.
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Search Alerts/Recalls
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