BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 1483789 · Received September 25, 2009

    Report

    Report Number
    2015691-2009-11690
    Event Type
    Injury
    Date Received
    September 25, 2009
    Date of Event
    August 26, 2009
    Report Date
    August 27, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS IS FOR REPORT ONLY, NO CUSTOMER LETTER WAS REQUESTED. DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO THE INFECTION. THIS WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED ON 25-SEP-2009, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 0.63 DURATION DUE TO ENDOCARDITIS AND REGURGITATION. PER THE CER: PERIMOUNT PLUS 6900P25MM WAS IMPLANTED TO CORRECT PVE AND MITRAL REGURGITATION IN 2009 DURING THE EVENT OF HVT002498. AT ABOUT ONE MONTH PRIOR, SYMPTOMS OF PVE WERE OBSERVED DURING USE OF PERIMOUNT PLUS 6900P25MM. CUSTOMER WAS MONITORING THE PATIENT. ON THE DAY OF THE PROCEDURE, EMERGENCY MVR OPERATION WAS CONDUCTED AND PERIMOUNT PLUS 6900P25MM REPORTED ON HVT002498 WAS EXPLANTED DUE TO MITRAL REGURGITATION. THIS REPORTED PERIMOUNT PLUS 6900P25MM WAS IMPLANTED AS A REPLACEMENT AND EXPLANTED DUE TO PVE AND MITRAL REGURGITATION AT ABOUT 3 WEEKS LATER. CUSTOMER COMMENTED THAT THERE WERE SEVERE VEGETATIONS OBSERVED ON LEAFLETS. ON-X 23MM WAS IMPLANTED AS A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 09B040

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention