BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS

    MDR report key: 10568916 · Received September 22, 2020

    Report

    Report Number
    2015691-2020-13681
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    August 28, 2020
    Report Date
    August 28, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. 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. 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 21MM AORTIC PERICARDIAL VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032569 CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 2900

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R