BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTINOL SELF-EXPANDING NITINOL STENT SYSTEM

    MDR report key: 3528750 · Received December 19, 2013

    Report

    Report Number
    2134265-2013-09180
    Event Type
    Injury
    Date Received
    December 19, 2013
    Report Date
    November 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    K032025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: ROCHA, LAURA, ET. AL. ¿ENDOVASCULAR APPROACH FOR PERIPHERAL ARTERIAL INJURIES,¿ ANNALS OF VASCULAR SURGERY, 27. 2013: 587¿593 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

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE PATIENT HAD A PSEUDOANEURYSM IN THE RIGHT COMMON ILIAC AS A COMPLICATION OF AN OPEN VASCULAR ANASTOMOSIS. THE INJURY WAS TREATED WITH A 10X100MM NON BSC GRAFT. A 9X42MM SENTINOL STENT WAS THEN PLACED INSIDE THE GRAFT TO CORRECT A KINKING. THE OUTCOME WAS NOTED AS THE GRAFT BEING PATENT AND THE PSEUDOANEURYSM BEING THROMBOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665687 SENTINOL SELF-EXPANDING NITINOL STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE UNK392

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other