BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS® SD RENAL/BILIARY

    MDR report key: 2961554 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00569
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    K040027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: 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, A STENT DISLODGED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT COMMON FEMORAL ARTERY. THE 80% STENOSED DENOVO TARGET LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS MESENTERIC ARTERY. DURING ADVANCEMENT OF A 6.0MMX18MMX90CM EXPRESS SD RENAL/BILIARY STENT DELIVERY SYSTEM (SDS) THROUGH A TIGHT ANGLE OFF THE AORTA, THE STENT DISLODGED AND MIGRATED TO THE RIGHT POPLITEAL ARTERY. A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE STENT. THE INTENDED PROCEDURE WAS NOT COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65241 EXPRESS® SD RENAL/BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74937912618900 14245089

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention