BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC SELF-EXPANDING NITINOL STENT WITH DELIVERY SYSTEM

    MDR report key: 2991670 · Received March 6, 2013

    Report

    Report Number
    2134265-2013-01188
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 FOLLOWING A STENT TREATMENT PROCEDURE, A DISSECTION AND THROMBOSIS OCCURRED. THE 90% STENOSED IRREGULARLY CONTOURED AND CONCENTRIC TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED RIGHT EXTERNAL ILIAC. A NON-BSC STENT WAS PLACED IN THE RIGHT COMMON ILIAC. THE RIGHT EXTERNAL ILIAC WAS PRE-DILATED AND THE EPIC STENT WAS IMPLANTED, THE STENT WAS ALSO POST DILATED. LATER THE SAME DAY THE PATIENT EXPERIENCED IN-STENT THROMBOSIS. THE LESION WAS TREATED WITH NON-BSC THROMBECTOMY DEVICE AND A DISSECTION WAS NOTED PROXIMAL AND DISTAL TO THE IMPLANTED EPIC STENT. THE AREAS OF DISSECTION WERE TREATED WITH TWO ADDITIONAL EPIC STENTS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95725 EPIC SELF-EXPANDING NITINOL STENT WITH DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE UNK122

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention