BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC¿

    MDR report key: 2972316 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-01081
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 PREMATURELY DEPLOYED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. PRIOR TO INSERTING INTO THE GUIDE CATHETER, THE DISTAL PORTION OF THE 5.0X122MM EPIC STENT WAS NOTED TO BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A 6.0X120MM EPIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD. 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
    76180 EPIC¿ CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74939054051220 15179857

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR