BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2142441 · Received June 28, 2011

    Report

    Report Number
    2015691-2011-15793
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 30, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: HOSPITAL WILL NOT RETURN DEVICE FOR EVALUATION. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. REQUESTS WERE MADE FOR SURGERY IMAGES AND ECHO ON CD. ECHOCARDIOGRAPHY HAS BEEN INTERPRETED BY AN INDEPENDENT CONSULTANT.

    Description of Event or Problem · 1

    REPORTEDLY, THE 19MM VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1.33 MONTHS DUE TO PROSTHETIC VALVE ENDOCARDITIS. THE CUSTOMER REPORTED THAT A MAGNA 3000J19 WAS IMPLANTED FOR AORTIC VALVE REPLACEMENT (AVR) DUE TO AORTIC REGURGITATION (AR) ON (B)(6) 2011 AT DIFFERENT HOSPITAL. TWO WEEKS AFTER THE OPERATION, PRESSURE GRADIENT (PG) BECAME 40MMHG AND HEART FAILURE BECAME WORSE. PATIENT WAS TRANSFERRED TO THIS HOSPITAL. ON ECHOCARDIOGRAPHY, MASSIVE ROD-SHAPED VEGETATION-LIKE MATERIAL WAS OBSERVED. PG WAS 60MMHG (MAX). C-REACTIVE PROTEIN (CRP) VALUE WAS 15. ANTIBIOTICS WERE ADMINISTRATED HOWEVER IT GOT WORSE AND THE EMERGENCY OPERATION WAS PERFORMED. THE MAGNA 3000J19 WAS EXPLANTED DUE TO PROSTHETIC VALVE ENDOCARDITIS (PVE) ON (B)(6) 2011. ANNULUS AREA WAS NOT ABSCESSED BUT FRAGILE. MASSIVE VEGETATION WAS OBSERVED ON THE VALVE. ST. JUDE MEDICAL HP 17MM WAS IMPLANTED AS A REPLACEMENT. CUSTOMER COMMENTED THAT THIS EXPLANT WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000 S-11A0191

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R