BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2124021 · Received June 14, 2011

    Report

    Report Number
    2015691-2011-15714
    Event Type
    Death
    Date Received
    June 14, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 16, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = BIOPROSTHESIS VEGETATION. EVALUATION: METHOD = DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE SUBJECT SERIAL NUMBER WAS TRACED TO ITS STERILITY LOT; AND THE COMPLAINT DATABASE INDICATES NO OTHER RELATED INFECTION/ENDOCARDITIS REPORTS RECEIVED FOR ANY DEVICES PROCESSED UNDER THE SAME STERILITY LOT. PROSTHETIC VALVE ENDOCARDITIS OCCURRING EARLY POST-OPERATIVELY, WITHIN 60 DAYS, IS USUALLY DUE TO PERIOPERATIVE BACTERIAL CONTAMINATION OF THE VALVE. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. THE HEALTHCARE PROVIDER INDICATES NO MALFUNCTION OF THE EDWARDS' DEVICE, AND THE INVESTIGATION REVEALS NOTHING TO INDICATE A QUALITY DEFICIENCY THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    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 LEARNED THAT THE EDWARDS' VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 1 MONTH. THROUGH FOLLOW-UP WITH THE HEALTHCARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO RECURRENT PROSTHETIC ENDOCARDITIS, AND A BENTALL REPLACEMENT OF THE AORTIC VALVE AND AORTIC ROOT WAS PERFORMED, PRIOR TO PATIENT EXPIRING DUE TO A CARDIAC ARREST. OPERATIVE REPORT INDICATES, " THE [SUBJECT] PROSTHETIC VALVE WAS REMOVED ALONG WITH ALL SUTURES AND PLEDGETS FROM THE PREVIOUS AORTIC VALVE IMPLANTATION. THE ANNULUS WAS EXTENSIVELY DEBRIDED. THE REGION OF THE PERIVALVULAR LEAK WAS NOTED IN THE RIGHT ANNULUS, NEAR THE LEFT-RIGHT COMMISSURE. THE LEFT COMMISSURE ALTHOUGH INTACT, WAS EXTENSIVELY UNDERMINED BY A NEW, LARGE ABSCESS PROTRUDING UNDER THE LEFT MAIN CORONARY ARTERY AND DESTROYING THE LEFT SINUS OF VALSALVA" OPERATIVE REPORT INDICATES THAT AFTER IMPLANTING THE NEW VALVE (SN (B)(4)) AND GRAFT, THE PATIENT HAD PROGRESSIVE DETERIORATION OF GLOBAL HEART FUNCTION, REQUIRING HIGH DOSE INOTROPES. ALSO STATED THAT DESPITE AUGMENTED SUPPORT, THE PATIENT'S HEMODYNAMICS CONTINUED TO DETERIORATE AND HE EVENTUALLY SUFFERED A CARDIAC ARREST, FROM WHICH HE COULD NOT BE RESUSCITATED. THE PATIENT EXPIRED ON DAY OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000 R-10F1541

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| H| R