BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2030030 · Received March 25, 2011

    Report

    Report Number
    2015691-2011-15093
    Event Type
    Death
    Date Received
    March 25, 2011
    Report Date
    February 24, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. OF NOTE, THE HEALTH-CARE PROVIDER WAS UNAWARE OF THE PATIENT'S DEATH; THEREFORE, THE CAUSE OF DEATH COULD NOT BE DETERMINED. 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 PATIENT HAS EXPIRED. THE DATE OF PATIENT'S DEATH AND IMPLANT DURATION WERE NOT PROVIDED. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE PATIENT'S OPERATIVE REPORT AND DISCHARGE SUMMARY WERE RECEIVED. ACCORDING TO THE REPORTS, THE PATIENT PRESENTED AORTIC INSUFFICIENCY AND THEREFORE, HAD AORTIC VALVE REPLACEMENT. THE PATIENT TOLERATED THE PROCEDURE IN SATISFACTORY CONDITION. POSTOPERATIVE TEE DEMONSTRATED NO AORTIC INSUFFICIENCY AND GOOD, OVERALL LV FUNCTION. POSTOPERATIVELY, THE PATIENT DEVELOPED HEPARIN-INDUCED THROMBOCYTOPENIA REQUIRING ANGIOMAX AND COUMADIN. HE DEVELOPED A LEFT FEMORAL THROMBUS. HE ALSO DEVELOPED HEALTH-CARE-ACQUIRED PNEUMONIA REQUIRING IV ANTIBIOTICS ON DISCHARGE. HE DID MUCH BETTER. HE UNDERWENT A BRONCHOSCOPY WHICH SHOWED MUCOUS PLUG DURING THE HOSPITALIZATION AS WELL. UPON DISCHARGE, ANGIOMAX WAS DISCONTINUED BUT THE PATIENT REMAINED ON COUMADIN. UNFORTUNATELY, NO OTHER DETAILS WERE PROVIDED. THE CAUSE OF DEATH REMAINS UNKNOWN. FURTHERMORE, THERE HAVE NOT BEEN ANY ALLEGATIONS THAT THE EDWARDS DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH; NO DEVICE MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX R-10E1245

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death