BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO¿ BALLOON-EXPANDABLE BILIARY STENT SYSTEM

    MDR report key: 2950590 · Received February 8, 2013

    Report

    Report Number
    2183870-2013-00035
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    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 WAS CONDUCTED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING THE RETURN OF THE DEVICE. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PROCEDURE WAS A STENT OF THE RIGHT RENAL VIA RIGHT COMMON FEMORAL ACCESS. THE PURPOSE WAS TO TREAT A POSSIBLE RENAL ARTERY STENOSIS OF THE TRANSPLANTED KIDNEY WHICH IS NOW FAILING. THE VISI-PRO DEVICE WAS PREPPED AND INSERTED THROUGH A 6 FRENCH SHEATH OVER A .035" WIRE. THE PHYSICIAN DECIDED THAT THE STENT WAS TOO LONG AND DECIDED TO REMOVE IT. THE STENT CAME LOOSE FROM THE BALLOON, BUT WAS STILL OVER THE WIRE. THE VISI-PRO WAS THEN GRASPED WITH ENDOCARDIAL BIOPSY FORCEPS TO WITHDRAW OVER THE WIRE INTO THE SHEATH. THE PHYSICIAN TRIED TO PULL THE VISI-PRO BACK THROUGH THE SHEATH WITH THE FORCEPS AND THEN TRIED TO SNARE THE VISI-PRO. THE PHYSICIAN DECIDED TO DO A CUT DOWN BECAUSE THE SHEATH HAD COME BACK AND THE STENT WAS NOT IN THE TISSUE TRACK, BUT STUCK IN THE WALL OF THE VESSEL. AFTER THE STENT WAS REMOVED THE PHYSICIAN UPSIZED THE SHEATH AND DEPLOYED A DIFFERENT BALLOON EXPANDABLE STENT ACROSS THE STENOSIS. THE PHYSICIAN THEN CLOSED THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53927 VISI-PRO¿ BALLOON-EXPANDABLE BILIARY STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. PXB35-06-27-135 9651900

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention HERCULINK