BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1953321 · Received January 7, 2011

    Report

    Report Number
    2015691-2011-14638
    Event Type
    Death
    Date Received
    January 7, 2011
    Date of Event
    October 4, 2010
    Report Date
    December 9, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THROMBOCYTOPENIA. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) IS CURRENTLY IN PROCESS.

    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 PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 1.5 MONTHS. UNFORTUNATELY, THE CAUSE OF DEATH WAS NOT PROVIDED. ACCORDING THE PATIENT'S DISCHARGE SUMMARY, THE PATIENT WAS ADMITTED FOR AORTIC VALVE REPLACEMENT (AVR). STATUS POST AVR, THE PATIENT EXPERIENCED COMPLICATIONS SUCH AS: CHRONIC ATRIAL FIBRILLATION, ANEMIA, THROMBOCYTOPENIA, CARDIOMYOPATHY WITH EF IMPROVED POST SURGERY. ON ECHO, (B)(6) 2010, SHOWED EF OF ABOUT 40%, WHICH WAS IN THE PAST, ABOUT 25%. THE PATIENT ASO HAD ACUTE ON CHRONIC DISEASE STATUS POST TRANSFUSION, HYPERNATREMIA, AND ACUTE RENAL FAILURE. THE PATIENT WAS DISCHARGED TO THE (B)(6) IN STABLE CONDITION. FURTHERMORE, THERE HAS BEEN NO ALLEGATIONS OF A PRODUCT 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 R-10E1360

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death