BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3180735 · Received June 20, 2013

    Report

    Report Number
    2015691-2013-20388
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 22, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THERE MAY BE CASES IN WHICH OUR DEVICES ARE IMPLANTED IN A PATIENT WITH ACTIVE NATIVE VALVE OR PROSTHETIC VALVE ENDOCARDITIS. IN THESE CASES, IT IS NOT UNUSUAL TO HAVE A RECURRENCE OF ENDOCARDITIS, AS THE ORGANISMS CAUSING THE ENDOCARDITIS WERE NEVER COMPLETELY ELIMINATED. THE OP REPORT INDICATES THAT THIS PATIENT INITIALLY HAD PLACEMENT OF THIS VALVE FOR ENDOCARDITIS CAUSED BY ONGOING DRUG ABUSE. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED WITHOUT THE SAMPLE DEVICE, IT APPEARS THAT THE RECURRENCE OF ENDOCARDITIS WAS LIKELY DUE TO THE PATIENT'S PREVIOUS INFECTION OR ONGOING DRUGE ABUSE. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION. OF NOTE, THIS PATIENT ALSO HAD AN EDWARDS ANNULOPLASTY RING EXPLANTED DURING THE SAME PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 6 MONTHS PROSTHETIC VALVE ENDOCARDITIS. PER THE OP REPORT, THE PATIENT INITIALLY HAD AORTIC VALVE REPLACEMENT (AVR) ALSO FOR ENDOCARDITIS DUE TO DRUG ABUSE. THE PATIENT MADE A RECOVERY. RECENTLY, HE WAS FOUND TO HAVE POSITIVE BLOOD CULTURES. ECHO SHOWED VEGETATIONS ON THE PROSTHETIC AORTIC VALVE. THEREFORE, REDO-AVR WAS SCHEDULED. THE PATIENT'S TISSUE WAS EXTREMELY EDEMATOUS. THE AORTIC VALVE WAS COVERED WITH VEGETATIVE MATERIAL. THERE WAS A ROOT ABSCESS UNDERNEATH THE LEFT MAIN CORONARY ARTERY. THERE WAS PARTIAL DEHISCENCE OF THE SUTURE LINE WITHOUT COMPLETE SEPARATION. THE DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. THE PATIENT WAS SEPARATED FROM CARDIOPULMONARY BYPASS WITHOUT DIFFICULTY. ONCE OFF BYPASS, ECHOCARDIOGRAPHY SHOWED NO PERIVALVULAR LEAKS IN THE AORTIC POSITION WITH A MEAN GRADIENT ACROSS THE AORTIC VALVE OF 6 MMHG AND NORMAL LV FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279994 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-11L4076

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R