BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS

    MDR report key: 12463297 · Received September 13, 2021

    Report

    Report Number
    2015691-2021-05161
    Event Type
    Injury
    Date Received
    September 13, 2021
    Date of Event
    August 10, 2021
    Report Date
    October 18, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL NARRATIVES: UPDATED D4, H4, AND H6 PER NEW INFORMATION RECEIVED. 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.

    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 THERE MAY BE CASES WHEN A TRANSCATHETER INTERVENTION IS INDICATED OR PERFORMED. ALTHOUGH THERE ARE MULTIPLE ROOT CAUSES, VALVES ARE TYPICALLY TREATED BECAUSE THEY ARE NOT FUNCTIONING OPTIMALLY. A VALVE-IN-VALVE PROCEDURE CARRIES SIGNIFICANT RISK. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION THAT A PATIENT WITH A 25MM AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO UNKNOWN REASONS. A TRANSCATHETER VALVE WAS IMPLANTED. AS REPORTED, THE PATIENT DIED SHORTLY AFTER VALVE PLACEMENT BECAUSE OF AN ACUTE AND UNEXPECTED LEFT CORONARY OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359537 CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2900

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R