BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIC ULTRA

    MDR report key: 2061169 · Received April 4, 2011

    Report

    Report Number
    2061169
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC INC
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    ELDERLY MALE WITH A HISTORY OF AORTIC VALVE REPLACEMENT WITH A 25MM PORCINE BIOPROSTHESIS, AS WELL AS A THREE-VESSEL CORONARY ARTERY BYPASS OPERATION LESS THAN 6 MONTHS AGO, INITIALLY DID WELL, BUT RECENTLY REDEVELOPED SIGNS AND SYMPTOMS OF AORTIC STENOSIS. THE VALVE WAS INTERROGATED BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND FOUND TO HAVE A RECURRENT STENOSIS WITH A MEAN GRADIENT OF ABOUT 55 MM OF MERCURY. IT HAD BEEN FUNCTIONING NORMALLY BY TEE AFTER THE ORIGINAL PROCEDURE. THE PATIENT WAS TAKEN TO OR FOR AORTIC VALVE REPLACEMENT WITH MECHANICAL PROSTHESIS DUE TO EARLY FAILURE OF THE OTHER PROSTHESIS.======================MANUFACTURER RESPONSE FOR PORCINE BIOPROSTHESIS, MEDTRONIC MOSAIC ULTRA 305======================THEY'VE PROVIDED THE OR WITH A RETURN SHIPPING SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC ULTRA PORCINE BIOPROSTHESIS LWR MEDTRONIC INC 25MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR