BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO BALLOON EXPANDABLE BILIARY STENT SYSTEM

    MDR report key: 3152267 · Received June 7, 2013

    Report

    Report Number
    2183870-2013-00141
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 13, 2013
    Manufacturer
    EV3 INC.
    Product Code
    NIN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PROCEDURE WAS A RIGHT RENAL ARTERIOGRAM. THE PATIENT HAD A 70% STENOSIS IN THE RIGHT RENAL. THE PHYSICIAN ACCESSED THE LEFT FEMORAL ARTERY AND PLACED THE 6FR SHEATH IN THE RIGHT RENAL. HE THEN ADVANCED THE VISI-PRO THROUGH THE SHEATH AND ONCE THE VISI-PRO STENT WAS INSIDE THE RIGHT RENAL HE PULLED THE SHEATH BACK 30MM. THEN THE PHYSICIAN ADVANCED THE STENT FORWARD THE STENT CAME OFF THE BALLOON CATHETER. THE PHYSICIAN DID NOT FEEL COMFORTABLE WHERE THE STENT WAS LOCATED SO HE SNARED THE STENT FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252922 VISI-PRO BALLOON EXPANDABLE BILIARY STENT SYSTEM STENT, RENA NIN EV3 INC. PXB35-06-17-080 9577316

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6F ANSEL SHEATH| .035 GLIDEWIRE