BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO¿ PTA BALLOON CATHETER

    MDR report key: 1963039 · Received January 18, 2011

    Report

    Report Number
    2183870-2011-00010
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 16, 2011
    Report Date
    December 20, 2011
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT AVAILABEL FOR THE INVESTIGATION.

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO DEPLOY A 9X27X80 VISI-PRO STENT IN THE LEFT COMMON ILIAC ON THE RIGHT SIDE WITH A SHORT 6F SHEATH. THE 9MM STENT IS INDICATED FOR A 7FM SHEATH. AFTER THE PHYSICIAN FORCED THE VISI-PRO STENT IN THE 6F SHEATH AND CROSSED OVER BIFURCATION WITH ONLY A WIRE IN PLACE, THE STENT SHEARED OFF THE BALLOON SYSTEM AND LANDED IN THE LEFT ILIAC. PHYSICIAN WAS ABLE TO GET THE BALLOON BACK IN THE STENT AND INFLATE IT IN THE LEFT ILIAC BUT NOT AT THE SITE OF BLOCKAGE. WITHOUT UPSIZING THE SHEATH TO A 7F LONG, PHYSICIAN TOOK ANOTHER VISI-PRO STENT 9X17X80 AND FORCED IT INTO THE SHORT SHEATH DISLODGING THE STENT ONTO THE RIGHT ILIAC. AFTER ATTEMPTING TO USE A SNARE TO REMOVE THE LOST, UNDEPLOYED STENT THE PATIENT WAS SENT TO THE OR TO HAVE THE SURGEON REMOVE FROM THE SECOND VISI-PRO FROM THE PATIENT. PLEASE REFERENCE MDR 2183870-2011-00009 FOR THE OTHER VISI-PRO STENT USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISI-PRO¿ PTA BALLOON CATHETER CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. PXB35-07-17-080 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6F SHORT SHEATH| VISI-PRO STENT| TRI-LOOP SNARE