BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC SELF-EXPANDING NITINOL VASCULAR STENT WITH DELIVERY SYSTEM

    MDR report key: 2001242 · Received February 24, 2011

    Report

    Report Number
    2134265-2011-00718
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Report Date
    January 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT MOVED UPON DEPLOYMENT. THE PHYSICIAN WAS TREATING A LESION LOCATED IN THE LEG WITH THIS 7X41X120 EPIC VASCULAR STENT. THE STENT "MIGRATED" A FEW MILLIMETERS DURING DEPLOYMENT. THE CASE WAS SUCCESSFUL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT DID WELL. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC SELF-EXPANDING NITINOL VASCULAR STENT WITH DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74939054074020 13830606

    Patients

    Seq Age Sex Outcome Treatment
    1