BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 3801101 · Received May 8, 2014

    Report

    Report Number
    2015691-2014-01067
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    September 10, 2009
    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. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION BECAUSE IT REMAINS IMPLANTED. THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROCESS. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE. ECHO RECORDS HAVE NOT BEEN MADE AVAILABLE. THIS PATIENT HAS AN ADDITIONAL BIOPROSTHETIC VALVE IMPLANTED TO THE PULMONARY POSITION. SEE REPORT FOR SERIAL NO. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE INITIAL INFORMATION RECEIVED INDICATED THAT A 21MM AORTIC VALVE IMPLANTED TO THE TRICUSPID POSITION HAD EXHIBITED SEVERE TRICUSPID REGURGITATION AT FOUR (4) YEARS, ONE (1) MONTH AFTER IMPLANT. INFORMATION WAS RECEIVED THAT CLARIFIED THE SCALE USED BY THE REPORTER (A SCALE OF 1 TO 6) ACTUALLY INDICATED THIS DEVICE WAS EXHIBITING MODERATE REGURGITATION. THERE ARE NO PLANS TO EXPLANT THIS DEVICE.

    Description of Event or Problem · 1

    EDWARDS HAS RECEIVED INFORMATION THAT A 21MM AORTIC VALVE IMPLANTED TO THE TRICUSPID POSITION HAS EXHIBITED SEVERE TRICUSPID REGURGITATION AT FOUR (4) YEARS, ONE (1) MONTH AFTER IMPLANT. DEVICE REMAINS IMPLANTED. THERE ARE NO ADVERSE PATIENT EFFECTS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277934 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1