BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2991497 · Received March 6, 2013

    Report

    Report Number
    2015691-2013-19449
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 6, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT EXPLANTED FROM PATIENT. UNFORTUNATELY, THE DEVICE WAS NOT EXPLANTED FROM THE PATIENT; THEREFORE, THE SOURCE OF THE REPORTED CALCIFICATION COULD NOT BE ASSESSED. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED, IT APPEARS THAT THE STENOSIS WAS LIKELY CAUSED BY THE CALCIFICATION. 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. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE PATIENT HAD RE-OPERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS AND 5 MONTHS DUE TO AORTIC STENOSIS WITH CALCIFICATION. ACCORDING TO THE OP REPORT, A 23 MM EDWARDS SAPIEN STENTED PERICARDIAL TISSUE VALVE WAS THEN ADVANCED ACROSS THE STENOTIC BIOPROSTHETIC VALVE. CARDIAC OUTPUT WAS ELIMINATED USING RAPID VENTRICULAR PACING. THE VALVE WAS DEPLOYED IN THE CORRECT POSITION, AFTER CORRECT POSITIONING WAS CONFIRMED WITH BOTH FLUOROSCOPY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY. TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED NOSIGNIFICANT PERIVALVULAR LEAK AFTER THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN STABLE CONDITION. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96190 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R