BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO¿ BALLOON-EXPANDABLE PERIPHERAL STENT SYSTEM

    MDR report key: 2200071 · Received August 10, 2011

    Report

    Report Number
    2183870-2011-00153
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 11, 2011
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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

    THIS PROCEDURE WAS PERFORMED IN (B)(6). DURING THE PROCEDURE THE VISI-PRO STENT DID NOT GO THROUGH THE STENOSIS IN ILIAC VESSEL. THE PHYSICIAN COULD NOT TAKE THE VISI-PRO STENT OUT FROM THE PATIENT'S VESSEL. THE STENT HAD TO BE REMOVED BY A SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISI-PRO¿ BALLOON-EXPANDABLE PERIPHERAL STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. PXP35-08-37-080 9386555

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention