Model Number 11500A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/14/2024 |
Event Type
Injury
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Event Description
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It was learned through implant patient registry that a patient with a 25mm 11500a aortic valve was explanted after an implant duration of 2 years, 4 months due to unknown reason.The explanted valve was replaced with a 25mm 11500a valve.The patient was in recovery post procedure.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 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 reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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Manufacturer Narrative
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Manufacturer narrative: intermediate, or late endocarditis (greater than 60 days post-implant) occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the patient's body and is not in any way related to the sterilization or packaging process of the device corrected data: 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 through implant patient registry and investigation that a patient with a 25mm 11500a aortic valve was explanted after an implant duration of 2 years, 4 months due to endocarditis.The explanted valve was replaced with a 25mm 11500a valve.The patient was in recovery post procedure.Pathology reports clinical history of prosthetic aortic valve endocarditis.
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Search Alerts/Recalls
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