BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO BALLOON EXPANDABLE BILIARY STENT SYSTEM

    MDR report key: 2904181 · Received January 9, 2013

    Report

    Report Number
    2183870-2013-00017
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    November 28, 2012
    Report Date
    December 17, 2012
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 DEPLOYED IN A FISTULA (B)(6) 2012. WHEN THE PATIENT RETURNED IN (B)(6) WITH SYMPTOMS, IT WAS FOUND THE STENT HAD FRACTURED. THE PHYSICIAN HAD TO PLACE A SECOND STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11985 VISI-PRO BALLOON EXPANDABLE BILIARY STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. PXB35-09-27-080 9584249

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention