BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPIC SELF-EXPANDING NITINOL STENT WITH DELIVERY SYSTEM

    MDR report key: 4899450 · Received July 8, 2015

    Report

    Report Number
    2134265-2015-04278
    Event Type
    Death
    Date Received
    July 8, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 15, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - DEVICE NOT RETURNED; THEREFORE, ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL INTERVENTION PROCEDURE THE PATIENT EXPIRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. AN EPIC SELF-EXPANDING SENT WAS IMPLANTED AT SOME POINT DURING THE PROCEDURE. DURING THE PROCEDURE THE ILIAC ARTERY RUPTURED. A NON-BSC COPPER STENT WAS USED IN ATTEMPT TO CLOSE THE RUPTURE HOWEVER WAS UNSUCCESSFUL AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443282 EPIC SELF-EXPANDING NITINOL STENT WITH DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE UNK122

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R