BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO¿ BALLOON-EXPANDABLE BILIARY STENT SYSTEM

    MDR report key: 2173043 · Received July 23, 2011

    Report

    Report Number
    2183870-2011-00141
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 22, 2011
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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

    THE VISI-PRO STENT WAS SUPPOSED TO BE PLACED IN THE SUBCLAVIAN ARTERY, HOWEVER, THE LESION WAS TOO TIGHT TO CROSS. THE STENT BECAME STUCK PROXIMAL TO THE LESION AND WOULD NOT PULL BACK WHEN TRYING TO RETRIEVE THROUGH THE SHEATH. THE PHYSICIAN HAD TO DEPLOY THE VISI-PRO AT THE CURRENT, NON TARGET LOCATION. 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. PXB35-08-27-135 9404653

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention