BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAT2 RESERVOIR W/OUTLET CLAP 30MCG FILTER

    MDR report key: 4093115 · Received September 10, 2014

    Report

    Report Number
    MW5038181
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    August 20, 2014
    Report Date
    September 5, 2014
    Manufacturer
    SORIN GROUP
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE WITH SEVERE AORTIC STENOSIS ADMITTED FOR TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). DURING TRANSCATHETER AORTIC VALVE DEPLOYMENT, THE BALLOON RUPTURED. WHEN ATTEMPTING TO REMOVE BALLOON, A PORTION OF IT REMAINED IN THE DISTAL AORTA. THE REMAINING DEVICE WAS SURGICALLY REMOVED AND THE FEMORAL ARTERY WAS SURGICALLY REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559640 BRAT2 RESERVOIR W/OUTLET CLAP 30MCG FILTER BRAT2 RESERVOIR W/OUTLET CLAP 30MCG FILTER DXE SORIN GROUP 1403190031

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R