BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC SELF-EXPANDING NITINOL STENT WITH DELIVERY SYSTEM

    MDR report key: 2801702 · Received October 23, 2012

    Report

    Report Number
    2134265-2012-06891
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    September 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: 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 PERIPHERAL STENTING TREATMENT PROCEDURE, STENT DEPLOYMENT ISSUES OCCURRED. THE PHYSICIAN COMMENTED THAT THE EPIC STENT "SLIPS" DISTALLY DURING DEPLOYMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIS STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC SELF-EXPANDING NITINOL STENT WITH DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE UNK122

    Patients

    Seq Age Sex Outcome Treatment
    1