BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 3803147 · Received May 9, 2014

    Report

    Report Number
    2015691-2014-01104
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    October 23, 2013
    Report Date
    April 11, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. MANUFACTURER NARRATIVE: THE DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION BECAUSE IT REMAINS IMPLANTED. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO RELATED NONCONFORMANCE. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE. ECHO REPORTS HAVE NOT BEEN MADE AVAILABLE. THE TYPE AND CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. TYPICALLY, MILD REGURGITATION IS NOT UNUSUAL AFTER INITIAL VALVE REPLACEMENT, AND IS USUALLY TOLERATED BY PATIENTS. OFTEN MODERATE TO HIGH REGURGITATION REQUIRING REOPERATION IN THE IMMEDIATE POST-OPERATIVE PERIOD IS DUE TO PROCEDURAL RELATED ISSUES AND IS UNRELATED TO THE DEVICE. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION. IN THIS CASE, THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS BECAUSE IT REMAINS IMPLANTED IN THE PATIENT. BASED ON THE AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM THE CLINICAL COMMENTS.

    Description of Event or Problem · 1

    EDWARDS HAS RECEIVED INFORMATION THAT A 25MM BIOPROSTHETIC VALVE HAS EXHIBITED MITRAL GRADIENT ABOVE THE EXPECTED RANGE (5.2±1.2), WITH SEVERE MITRAL REGURGITATION AT ONE (1) YEAR, SIX (6) MONTHS AFTER IMPLANT. DEVICE REMAINS IMPLANTED. THERE ARE NO ADVERSE PATIENT EFFECTS REPORTED AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED AT A LATER DATE INDICATED THAT PATIENT EXHIBITED SEVERE MITRAL REGURGITATION AT ONE (1) YEAR, FOUR (4) MONTHS, ONE (1) YEAR, SIX (6) MONTHS, AND ON AN UNKNOWN DATE POST-OPERATIVELY PER ECHO RECORDINGS. ECHOS WERE REVIEWED BY AN INDEPENDENT REVIEWER, WHO INDICATED THAT PROSTHETIC LEAFLETS PRESENTED AS THICKENED AND MITRAL REGURGITATION AND MITRAL STENOSIS WERE PROGRESSIVE. THE DEVICE FUNCTION APPEARED TO HAVE BEEN ABNORMAL SINCE IMPLANT. PATIENT HAS SINCE RECEIVED VALVE IN VALVE INTERVENTION WITH POST-PROCEDURE OUTCOME AS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281852 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 7000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR