BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 3801492 · Received May 9, 2014

    Report

    Report Number
    2015691-2014-01085
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 6, 2011
    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

    ADDITIONAL INFORMATION RECEIVED INDICATES VALVE LEAFLETS WERE RIGID SINCE IMPLANT WITH MR 1-2 VS MR2. (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL 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 RECORDS 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 27MM MITRAL BIOPROSTHETIC VALVE EXHIBITED SEVERE MITRAL REGURGITATION AT FIVE (5) MONTHS AFTER MITRAL VALVE IMPLANTATION AND CABG X2. THREE (3) YEARS, THREE (3) MONTHS LATER, THE MITRAL REGURGITATION REMAINED SEVERE. THROUGH INVESTIGATION, IT WAS LEARNED THIS PATIENT EXPIRED. THE DATE AND CAUSE OF DEATH IS UNKNOWN. DEATH OCCURRED APPROXIMATELY THREE (3) YEARS, THREE (3) MONTHS AFTER IMPLANT. THE DEVICE REMAINED IMPLANTED. PRIOR TO HOSPITALIZATION, THE PATIENT REPORTEDLY HAD WEAKNESS, POOR APPETITE, SHORTNESS OF BREATH, DROWSINESS, PALPITATIONS, OLIGURIA AND MALAISE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES VALVE LEAFLETS WERE RIGID SINCE IMPLANT WITH MR 1-2 VS MR2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280497 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 7000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR