BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC? VASCULAR

    MDR report key: 3870011 · Received June 12, 2014

    Report

    Report Number
    2134265-2014-03232
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIO
    PMA / PMN Number
    P110035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 WS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS IN THE ILIAC ARTERY. AN EPIC VASCULAR 8X40X75 STENT WAS ADVANCED AND DEPLOYED TO TREAT THE TARGET LESION. A BALLOON WAS THEN ADVANCED BUT GOT "CAUGHT" AND WAS UNABLE TO MOVE. IT WAS NOTED THAT THE INNER CATHETER OF THE EPIC STENT DELIVERY SYSTEM HAD DETACHED AND WAS STILL ON THE GUIDEWIRE. THE INNER CATHETER WAS REMOVED BACK OUT OVER THE WIRE. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348230 EPIC? VASCULAR STENT, ILIAC NIO BOSTON SCIENTIFIC - MAPLE GROVE H74939200084070

    Patients

    Seq Age Sex Outcome Treatment
    1