BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS

    MDR report key: 11642049 · Received April 9, 2021

    Report

    Report Number
    2015691-2021-02374
    Event Type
    Injury
    Date Received
    April 9, 2021
    Report Date
    May 14, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL NARRATIVES . UPDATED H6 PER NEW INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS, MODEL# 2800, PMA# P860057/S001. IT WAS REPORTED THAT THE PATIENT HAD OR IS BEING EVALUATED TO UNDERGO TRANSCATHETER VALVE REPLACEMENT (VALVE-IN-VALVE). THE REASON FOR THE VALVE-IN-VALVE INTERVENTION IS UNKNOWN. ALTHOUGH THERE ARE MULTIPLE ROOT CAUSES, VALVES ARE TYPICALLY TREATED BECAUSE THEY ARE NOT FUNCTIONING OPTIMALLY. RE-OPERATIVE VALVE SURGERY AND VALVE-IN-VALVE INTERVENTION CARRY SIGNIFICANT RISK. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINS IMPLANTED. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORD (DHR) WAS NOT ABLE TO BE REVIEWED AS THE DEVICE SERIAL NUMBER WAS NOT PROVIDED. 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

    EDWARDS RECEIVED INFORMATION THAT A PATIENT WITH A 21MM AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASON AFTER AN APPROXIMATE IMPLANT DURATION OF 14 YEARS. A NON-EDWARDS VALVE WAS IMPLANTED IN REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539073 CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2900J

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R