BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2070072 · Received April 26, 2011

    Report

    Report Number
    2015691-2011-15341
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    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. IN THIS CASE, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED ON THE SAME DAY OF SURGERY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT AFTER IMPLANTING THE VALVE, THERE WAS BLEEDING DETECTED. IT WAS DECIDED THAT THE PATIENT NEED AN AORTIC ROOT REPLACEMENT, AND THEREFORE, THE VALVE WAS REMOVED. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT PRESENTED WITH AORTIC STENOSIS AND AORTIC INSUFFICIENCY. THEREFORE, AN AORTIC VALVE REPLACEMENT WAS PERFORMED WITH THE EDWARDS VALVE. THE NATIVE AORTIC VALVE WAS NOTED TO BE HEAVILY CALCIFIED. THERE WAS CALCIUM EXTENDING UP THE ANTERIOR WALL OF THE AORTA. THE VALVE WAS COMPLETELY EXCISED AND THE ANNULUS DEBRIDED. THE EDWARDS VALVE WAS SEWN IN WITH GOOD POSITION. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS (CPB) WHEN HE STARTED TO HAVE INCREASED AMOUNTS OF BLEEDING FROM THE ANTERIOR SURFACE OF THE AORTA. ATTEMPTS WERE MADE TO EVALUATE THIS AND CONTROL THIS WITH PLEDGET SUTURES; HOWEVER, THIS WAS UNSUCCESSFUL AND THEREFORE, THE HEART WAS REARRESTED. THE AORTA WAS EVALUATED AND IT WAS APPARENT THAT THE FRACTURE ZONE OF THE CALCIFICATION OF THE AORTA HAD ESSENTIALLY SEPARATED THE AORTA FROM THE AORTIC ANNULUS. BECAUSE OF THIS, IT WAS NECESSARY TO PERFORM AORTIC ROOT REPLACEMENT ON THIS PATIENT. THE EDWARDS VALVE WAS REMOVED, THE AORTIC ROOT WAS REPAIRED, AND AN AORTIC VALVE CONDUIT WAS PLACED. PER THE SURGEON, THERE WAS NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX S-10J2584RF

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention