BEUDAMED
    FDA Adverse Event Death Summary report: N

    V8 TRANSLUMINAL BAV CATHETER

    MDR report key: 3892018 · Received June 19, 2014

    Report

    Report Number
    3010133561-2014-00002
    Event Type
    Death
    Date Received
    June 19, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 13, 2014
    Manufacturer
    INTERVALVE INC.
    Product Code
    OZT
    PMA / PMN Number
    K133607
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEVICE MALFUNCTION. THIS REPORT WAS SUBMITTED BECAUSE OF PT DEATH.

    Description of Event or Problem · 1

    THE OPERATOR USED A 21MM V8, LOT #101639, TO PRE-DILATE THE AORTIC VALVE BEFORE PLACEMENT OF THE COREVALVE DEVICE. THE V8 WAS INFLATED DURING RAPID VENTRICULAR PACING WITH APPROX 28CC OF SALINE/CONTRAST SOLUTION. UPON DEFLATION, THE PT'S ARTERIAL PRESSURE PLUMMETED. IMMEDIATE RESUSCITATION EFFORTS WERE INITIATED. THE PT DID NOT RECOVER A BLOOD PRESSURE AND EXPIRED. REVIEW OF THE CT SCAN AND CINE CONFIRMED THAT THE BALLOON WAS PROPERLY SIZED. THE V8 BALLOON INFLATION WAS STABLE AND INFLATED AND DEFLATED NORMALLY. FLUORO OBSERVATION OF CONTRAST EXTRAVASATION INTO THE PERICARDIAL SPACE LIKELY DUE TO AORTIC ROOT RUPTURE. NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361805 V8 TRANSLUMINAL BAV CATHETER BALLOON AORTIC VALVULOPLASTY CATHETER OZT INTERVALVE INC. 212612C110 101639

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death