BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO¿ BALLOON-EXPANDABLE BILIARY STENT SYSTEM

    MDR report key: 2841976 · Received November 21, 2012

    Report

    Report Number
    2183870-2012-00220
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 25, 2012
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    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

    (B)(4) 2012 ADDITIONAL INFORMATION RECEIVED: STANFORD TYPE B AORTIC DISSECTION EXTENDING INTO THE LEFT RENAL ARTERY. MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE VISI-PRO STENT INTO THE STENOSED SEGMENT OF THE LEFT RENAL ARTERY UNSUCCESSFULLY SECONDARY TO THE HIGH ACUTE ANGULATION WITH THE AORTA. IN THE PROCESS OF ADVANCING THE VISI-PRO STENT, IT BECAME DISLODGED AND MOVED INTO THE RIGHT COMMON ILIAC ARTERY. THEREFORE, AN ENSNARE DEVICE WAS USED SUCCESSFULLY TO SNARE AND RETRIEVE IT COMPLETELY FROM THE ARTERIAL SYSTEM THROUGH THE SHEATH.

    Description of Event or Problem · 1

    THE PROCEDURE WAS IN THE RIGHT RENAL ARTERY. THE VISI-PRO STENT DETACHED AND WAS FOUND IN THE RIGHT ILIAC.

    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. PXB35-05-37-135 9386005

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention