BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT® MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 5250297 · Received November 25, 2015

    Report

    Report Number
    2015691-2015-03213
    Event Type
    Injury
    Date Received
    November 25, 2015
    Date of Event
    October 28, 2015
    Report Date
    October 28, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THIS DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION BECAUSE IT REMAINS IMPLANTED AFTER A VALVE-IN-VALVE PROCEDURE. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. 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. IN THIS CASE, MINIMAL INFORMATION REGARDING THIS PROCEDURE HAS BEEN MADE AVAILABLE AND SUBSEQUENT ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THE CONDITION OF THE DEVICE AT THE TIME OF THE INTERVENTION OR INFORMATION ON THE PATIENT'S CONDITION OR POSSIBLE COMORBIDITIES HAVE BEEN UNSUCCESSFUL; THEREFORE, THE ROOT CAUSE FOR THE INTERVENTION REMAINS INDETERMINABLE. THE IFU WAS REVIEWED AND NO INADEQUACIES WERE IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. NO CORRECTIVE ACTION IS APPLICABLE TO THIS CASE; HOWEVER, EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A PATIENT WITH A 25 MM PERICARDIAL MITRAL VALVE IMPLANTED FOR FIVE (5) YEARS, EIGHT (8) MONTHS, AND THREE (3) DAYS UNDERWENT A VALVE-IN-VALVE PROCEDURE WITH A 26 MM TRANSCATHETER VALVE. THE REASON FOR THE VALVE-IN-VALVE PROCEDURE WAS NOTED AS STENOSIS DUE TO CALCIFICATION. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    PER OBTAINED OPERATIVE REPORT, THE PATIENT PRESENTED WITH INCREASING DYSPNEA AND ECHOCARDIOGRAM REVEALED SEVERE PROSTHETIC VALVE STENOSIS. DURING THE PROCEDURE, THE 26 MM TRANSCATHETER VALVE WAS DEPLOYED IN THE CORRECT POSITION AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A NORMAL FUNCTIONING PROSTHETIC VALVE WITH A TRACE OF PARAVALVULAR LEAK. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATION AND WAS TRANSFERRED TO INTENSIVE CARE UNIT IN STABLE CONDITION. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY TWENTY (20).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780129 CARPENTIER-EDWARDS PERIMOUNT® MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R