BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3024309 · Received March 27, 2013

    Report

    Report Number
    2015691-2013-19676
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 28, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED. IT WAS REPORTED THAT THIS VALVE WAS EXPLANTED DUE TO ENDOCARDITIS AND PERIVALVULAR LEAK (PVL). PVL CAN OCCUR IN THE MITRAL AND AORTIC POSITION FOR SIMILAR REASONS. IN THE EARLY POSTOPERATIVE PERIOD, THE HIGHEST INCIDENCE OF PVL HAS BEEN SEEN IN PATIENTS DEVELOPING INFECTIVE ENDOCARDITIS, WHICH IS MOST LIKELY ATTRIBUTED TO INADEQUATE PERI-OPERATIVE ANTIBIOTIC PROPHYLAXIS OR NOSOCOMIAL INFECTION. 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. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. IN THIS CASE, THE PATIENT'S MEDICAL RECORDS INDICATE AN INFECTED PACEMAKER LEAD THAT WAS REMOVED THIS PAST DECEMBER. BASED ON THIS INFORMATION, IT IS POSSIBLE THAT THIS CONTRIBUTED TO THE PATIENT'S INFECTED PROSTHETIC VALVE. UNFORTUNATELY, THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED WITH OUT THE SAMPLE DEVICE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 5 MONTHS DUE TO ENDOCARDITIS AND PERIVALVULAR LEAK (PVL). PRE-OP TEE SHOWED A LARGE PVL WITH POSSIBLE VEGETATIONS. THE DEVICE WAS EXPLANTED AND A NEW EDWARDS BIOPROSTHETIC VALVE WAS IMPLANTED. HIS RECOVERY WENT FAIRLY WELL. HE WAS RELEASED TO HOME IN SATISFACTORY CONDITION. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125443 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-10E1195

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R