BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISI-PRO BALLLOON EXPANDIBLE BILIARY STENT

    MDR report key: 2253533 · Received August 24, 2011

    Report

    Report Number
    1219977-2011-00006
    Event Type
    Other
    Date Received
    August 24, 2011
    Report Date
    August 19, 2011
    Manufacturer
    EV3 CORPORATE, WORLD HEADQUARTERS, PERIPHERAL VASCULAR
    Product Code
    FGE
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE MFR-CONTACT NAME AND ADDRESS (E3) LISTS THE MANUFACTURER AS ATRIUM MEDICAL, BASED ON THE DESCRIPTIONS IN FIELDS LISTED BELOW, ATRIUM BELIEVES THIS IS A DEVICE DISTRIBUTED BY EV3 INC. THE PRODUCT DESCRIPTION, LOT NUMBER AND PART NUMBER ARE NOT CONSISTENT WITH ANY DEVICE ATRIUM MANUFACTURES. MODEL: VISI-PRO 8MM X 37MM, LOT - 9419600, (B)(4). A VISI-PRO PRODUCT BROCHURE OBTAINED FROM THE EV3 INC. (B)(4). THE BROCHURE LISTS PRODUCT CODE PXB35-08-37-0 AS A 8MM X 37MM STENT. ATRIUM DOES NOT INCLUDE A 8MM X 37MM IN ITS FAMILY OF COVERED STENTS.

    Description of Event or Problem · 1

    AS REPORTED TO ATRIUM VIA MAUDE EVENT REPORT RECEIVED (B)(6) 2011: PATIENT AORTA DISEASE FOR BILATERAL ILIAC STENT. LEFT ILIAC STENT SHEARED OFF THE SHAFT (BALLOON EXPANDABLE STENT) AND LODGED IN EXTERNAL ILIAC. PATIENT NEEDED LEFT FEMORAL EXPLORATION AND PLACEMENT OF THIRD STENT TO CORRECT DISLODGED STENT. (STILL IN PATIENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISI-PRO BALLLOON EXPANDIBLE BILIARY STENT NONE FGE EV3 CORPORATE, WORLD HEADQUARTERS, PERIPHERAL VASCULAR PXB35-08-37-0 9419600

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK