BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESES

    MDR report key: 3811315 · Received May 15, 2014

    Report

    Report Number
    2015691-2014-01143
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 29, 2014
    Report Date
    May 1, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION BECAUSE IT REMAINS IMPLANTED. HOWEVER, THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO RELATED NONCONFORMANCE. 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

    REPORTEDLY, CENTRAL INSUFFICIENCY GRADE 3+ WAS DETECTED INTRAOPERATIVELY ON ECHO AFTER IMPLANT OF A 25MM MITRAL VALVE. THE SURGEON INDICATED A CUSP SEEMS NOT TO CLOSE PROPERLY; HOWEVER, THE SURGEON DECIDED NOT TO REOPEN THE PATIENT AND REPLACE THE DEVICE. THE 25MM VALVE REMAINS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD INTERNAL CARDIAC MASSAGE AFTER IMPLANT OF THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290309 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESES HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 7300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR