BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC¿

    MDR report key: 3013452 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01739
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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; 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 PREMATURELY DEPLOYED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A .035 ZIPWIRE WAS PLACED AND PRE-DILATION WAS PERFORMED WITH A NON BSC BALLOON. THE 7.0X118MM EPIC STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED ON THE WIRE. PRIOR TO ENTERING THE PATIENT, THE SDS BECAME STUCK ON THE WIRE AND THE EPIC STENT DEPLOYED. THE DEVICES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME EPIC STENT AND ANOTHER UNSPECIFIED GUIDE WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116150 EPIC¿ CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74939054071220 15545701

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR