BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO¿ BALLOON-EXPANDABLE BILIARY STENT SYSTEM

    MDR report key: 2834023 · Received November 15, 2012

    Report

    Report Number
    2183870-2012-00215
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    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 MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING STENT PLACEMENT IN THE LEFT RENAL ARTERY, THE VISI-PRO STENT BEGAN TO STRIP OFF THE BALLOON. THE STENT HAD TO BE DEPLOYED IN A POSITION NOT DESIRED BY THE PHYSICIAN. A SECOND STENT HAD TO BE USED TO COVER THE LESION. NO INJURY TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISI-PRO¿ BALLOON-EXPANDABLE BILIARY STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. PXB35-05-17-135 9630381

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention 6X17 VISI-PRO| 4X2 EVERCROSS