Model Number 11500A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Endocarditis (1834); Insufficient Information (4580)
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Event Date 10/31/2023 |
Event Type
Injury
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Manufacturer Narrative
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The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information is in process.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.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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Event Description
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Through implant patient registry it was learned a 25mm 11500a aortic valve was explanted after two (2) years, four (4) months, due to unknown reasons.The explanted device was replaced with a 25mm 11060a aortic valved conduit.Explant was not due to deficiency of the surgical valve.Patient post-operative status noted as in recovery.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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The cause of the event was most likely due to patient conditions.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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Through implant patient registry and investigation, it was learned a 25mm 11500a aortic valve was explanted after two (2) years, four (4) months, due to endocarditis and a root abscess.The valve itself appeared intact and normal outside of infection.The explanted device was replaced with a 25mm 11060a aortic valved conduit.Explant was not due to deficiency of the surgical valve.Patient post-operative status noted as in recovery.
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Search Alerts/Recalls
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