BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2893828 · Received January 2, 2013

    Report

    Report Number
    2015691-2013-18989
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    October 29, 2012
    Report Date
    December 4, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE SAMPLE DEVICE WAS NOT RETURNED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED. FOLLOW UP FOR ADDITIONAL INFORMATION IS CURRENTLY BEING MADE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT THAT ANY NEW INFORMATION IS RECEIVED. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION. A RELATED 3500A INITIAL REPORT WILL BE SUBMITTED FOR MODEL NUMBER 3000; SERIAL NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). "VEGETATIONS". BASED ON THE OPERATIVE REPORT RECEIVED FORM THE HEALTH-CARE PROVIDER, THE PATIENT HAD BEEN OPERATED ON TWICE BEFORE FOR BACTERIAL ENDOCARDITIS. SHE HAS RECURRENT PROSTHETIC VALVE ENDOCARDITIS OF HER AORTIC AND MITRAL VALVE AND ALSO SEVERE MITRAL STENOSIS. TEE SHOWED VEGETATIONS OF BOTH VALVES. THE MITRAL VALVE WAS EXPOSED AND IT HAD VEGETATIONS ON IT AS WELL AS SOME LAMINATED CLOT ALONG THE FREE ATRIAL WALL WHICH WAS REMOVED. THE VALVE WAS QUITE STIFF. THE VALVE WAS EXCISED AND REPLACED WITH A 27MM EDWARDS VALVE. ATTENTION WAS THEN REDIRECTED TO THE AORTIC VALVE. ANNULUS DID NOT HAVE A LOT OF GOOD TISSUE. IT WAS DEBRIDED THOROUGHLY AND THEN A SIZE 21MM EDWARDS VALVE WAS THEN SEATED. TEE OF THE HEART REVEALED THE AORTA TO BE THOROUGHLY DEAIRED, AND EXAMINATION OF THE VALVES JUST PRIOR TO SEPARATION FROM BYPASS REVEALED TO BE WELL SEATED WITHOUT EVIDENCE OF PERIVALVULAR LEAKAGE OR STENOSIS. THE PATENT WAS THEN SEPARATED FROM CARDIOPULMONARY BYPASS. THE PATIENT WAS TRANSFERRED FROM THE OPERATING ROOM TO THE ICU. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. IN THIS CASE, PER THE OP REPORT, ¿THE PATIENT HAD BEEN OPERATED ON TWICE BEFORE FOR BACTERIAL ENDOCARDITIS. SHE HAS RECURRENT PROSTHETIC VALVE ENDOCARDITIS OF HER AORTIC AND MITRAL VALVE.¿ ALSO, TEE SHOWED VEGETATIONS OF BOTH VALVES WHICH ARE TYPICALLY A COMPLICATION OF ENDOCARDITIS. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    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 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 60 MONTHS. UNFORTUNATELY, THE REASON FOR EXPLANT HAS NOT BEEN PROVIDED. NO OTHER DETAILS REPORTED. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION OR QUALITY DEFICIENCY. THE SUBJECT DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R