BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 11986127 · Received June 11, 2021

    Report

    Report Number
    2015691-2021-03536
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 11, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINED IMPLANTED. IN THIS CASE, MINIMAL INFORMATION REGARDING THIS PROCEDURE WAS RECEIVED AND ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THE CONDITION OF THE DEVICE, PATIENT'S MEDICAL HISTORY, OR POSSIBLE COMORBIDITIES HAVE BEEN UNSUCCESSFUL. THE ROOT CAUSE OF THE EVENT REMAINS INDETERMINABLE. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 PERICARDIAL VALVE IN THE AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO UNKNOWN REASONS. A NON-EDWARDS TRANSCATHETER VALVE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878359 NI REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2900

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R