BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 8805430 · Received July 18, 2019

    Report

    Report Number
    2015691-2019-02660
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    June 26, 2019
    Report Date
    June 26, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    STENOSIS, WHICH DEVELOPS PROGRESSIVELY OVER TIME, CAN BE DUE TO A NUMBER OF ISSUES. ADDITIONALLY, THERE CAN BE A NUMBER OF POTENTIAL KNOWN AND UNKNOWN PATIENT RELATED CONTRIBUTING FACTORS. SVD, A COMMON REASON FOR BIOPROSTHESIS EXPLANT OR REOPERATION, ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFIC AND NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES, OCCURRING SINGULARLY OR CONCOMITANTLY, MAY CONTRIBUTE TO STENOSIS AND/OR REGURGITATION. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINED IMPLANTED. THEREFORE, THE ROOT CAUSE FOR THE STENOSIS REMAINS INDETERMINABLE. HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE PATIENT¿S UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO A MANUFACTURING DEFICIENCY AND/OR ONE WAS NOT CONFIRMED THROUGH INVESTIGATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT INITIALLY IMPLANTED WITH A 23MM PERICARDIAL AORTIC VALVE FOR 6 YEARS 3 MONTHS IS HAVING AN EXPLANT PROCEDURE COMPLETED DUE TO STENOSIS. THE SECONDARY PROCEDURE HAS BEEN SCHEDULED BUT NOT COMPLETED. THE PHYSICIAN IS PLANNING ON IMPLANTING A NON-EDWARDS MECHANICAL VALVE. THE CURRENT PATIENT STATUS IS UNKNOWN. NO ALLEGED DEVICE FAILURE/MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599498 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX23MM

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R