BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3011775 · Received March 19, 2013

    Report

    Report Number
    2015691-2013-19588
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 18, 2013
    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

    (B)(4). DEVICE NOT RETURNED. 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, THE SURGEON INDICATED THAT THERE WAS NO MALFUNCTION OF THE EDWARDS VALVE. "GI TRACT" WAS PROVIDED HAS THE INFECTION SOURCE. UNFORTUNATELY, THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED WITHOUT 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 1 YEAR AND 6 MONTHS DUE TO PROSTHETIC VALVE ENDOCARDITIS. THE SURGEON INDICATED THAT THERE WAS NO MALFUNCTION OF THE EDWARDS DEVICE. "GI TRACT" WAS NOTED AS THE INFECTION SOURCE. ACCORDING TO THE OP REPORT, THE PATIENT HAS A PRIOR HISTORY OF ENDOCARDITIS OF THE AORTIC VALVE FOR WHICH HE UNDERWENT AORTIC VALVE REPLACEMENT (AVR). HE WAS ALSO NOTED TO HAVE SEPSIS. TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED MULTIPLE VEGETATIONS OF THE AORTIC VALVE AND THE PATIENT HAS SUFFERED AN EMBOLIC CVA. BECAUSE OF THE CONDITION OF THE AORTIC VALVE AND ONGOING SEPSIS, THE PATIENT WAS RECOMMENDED FOR REDO AVR. UPON INSPECTION, THE AORTIC PROSTHESIS WAS CONFIRMED TO HAVE MULTIPLE VEGETATIONS. THE DEVICE WAS REMOVED AND THE ANNULUS WAS EXTENSIVELY DEBRIDED. A LARGE ABSCESS WAS IDENTIFIED IN THE JUNCTION OF THE LEFT CORONARY SINUS AND THE RIGHT CORONARY SINUS.THIS AREA WAS EXTENSIVELY DEBRIDED AND DRAINED FROM PURULENT MATERIAL. THIS AREA WAS THEN REPAIRED WITH A PATCH OF PERICARDIUM THAT WAS EXTENDED INTO THE ANNULUS. A NEW EDWARDS BIOPROSTHETIC VALVE WAS SELECTED AND SATISFACTORY POSITIONING AND FUNCTIONING WAS CONFIRMED THROUGH INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM. THERE WERE NO PERIVALVULAR LEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114748 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R