BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2983076 · Received February 28, 2013

    Report

    Report Number
    2015691-2013-19412
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 30, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONFIRMED. REGURGITATION/INSUFFICIENCY IS CONSIDERED TO BE A PERIVALVULAR LEAK (PVL) IF A TURBULENT ECCENTRIC JET ORIGINATES BETWEEN THE BIOPROSTHETIC SEWING RING AND THE ANNULUS. WHILE THE MAJORITY OF AFFECTED PATIENTS ARE ASYMPTOMATIC, PVL, WHEN SEVERE, CAN LEAD TO SIGNIFICANT MORBIDITY INCLUDING HEART FAILURE AND HEMOLYTIC ANEMIA. 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. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED, IT APPEARS THAT THE PERIVALVULAR LEAK WAS LIKELY AS RESULT OF THE PATIENT'S BOUT OF ENDOCARDITIS IN 2010. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THE AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2 YEARS AND 5 MONTHS. ACCORDING TO THE OP REPORT, THIS IS A (B)(6) MALE WHO PRESENTED WITH SEVERE AI IN THE SETTING OF ENDOCARDITIS IN 2010. HE WAS FOUND TO HAVE AORTIC VALVE ENDOCARDITIS WITH EXTENSION INTO THE ROOT. THIS WAS REPAIRED ELSEWHERE WITH PERICARDIAL PATCH AND HE WAS DOING FINE UNTIL 2 WEEKS AGO WHEN HE PRESENTED IN HEART FAILURE TO AN OUTSIDE HOSPITAL. THE PATIENT UNDERWENT CPR FOR CARDIOPULMONARY ARREST ASSOCIATED WITH DIURESIS. THE PATIENT NOW HAS FULLY RECOVERED FROM A CARDIAC STANDPOINT, BUT STILL HAS SEVERE AI, EF OF 30%, AND WHAT APPEARS TO BE PSEUDOANEURYSM AND ASSOCIATED SEVERE PERIVALVULAR LEAK ON TRANSESOPHAGEAL ECHO. IT WAS NOTED THAT THE PATIENT'S PREVIOUS TISSUE VALVE WAS VISUALIZED AND FOUND TO BE FOR THE MOST PART INTACT WITHOUT EVIDENCE OF DEGENERATION OF THE LEAFLETS; HOWEVER, THERE WAS A LARGE PERIVALVULAR LEAK ASSOCIATED WITH LVOT BETWEEN THE RIGHT AND LEFT CORONARY. THE DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. TRANSESOPHAGEAL ECHO CONFIRMED THAT THERE WAS ONLY A TRACE PERIVALVULAR LEAK. THE PATIENT WAS DISCHARGED HOME ON POD #6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87683 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX R-10C0727

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R