BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 2912361 · Received January 11, 2013

    Report

    Report Number
    2015691-2013-19095
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 17, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROGRESS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO THE PATIENT (B)(6) FOR (B)(6). PATIENT STATUS AT TIME OF REPORT WAS LISTED AS STABLE. NO PATIENT STATUS UPDATE HAS BEEN PROVIDED. TWO DEVICES WERE EXPLANTED IN THE SAME SURGERY -- MITRAL VALVE AND AORTIC VALVE -- FOR THE SAME REASON. SEE REPORT FOR S/N (B)(4). THE CUSTOMER REPORT INDICATES THAT AN OPERATIVE REPORT IS AVAILABLE; HOWEVER, IT HAS NOT BEEN PROVIDED. CALCIFICATION IS A WELL-RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION.

    Additional Manufacturer Narrative · 1

    THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    REPORTEDLY, BOTH THE PATIENT'S MITRAL AND AORTIC VALVE WERE EXPLANTED AFTER AN IMPLANT DURATION OF 80.17 MONTHS (6 YEARS, 8 MONTHS) DUE TO STENOSIS. CUSTOMER REPORTED: SEVERE STENOSIS TO AORTIC AND MITRAL VALVE DUE TO CALCIFICATIONS. AT TIME OF REPORT, PATIENT CONDITION WAS REPORTED AS STABLE. DEVICES WILL NOT BE RETURNED DUE TO PATIENT (B)(6) FOR (B)(6). SEE REPORT FOR S/N (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18022 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 7000TFX 06B030

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R