BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXPRESS¿ VASCULAR SD

    MDR report key: 2970436 · Received February 20, 2013

    Report

    Report Number
    2134265-2013-00775
    Event Type
    Death
    Date Received
    February 20, 2013
    Date of Event
    December 24, 2012
    Report Date
    January 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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

    SAME CASE AS MFR #: 2134265-2013-00774. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, GUIDE WIRE REMOVAL DIFFICULTIES AND STENT MIGRATION OCCURRED. THE +/-50% STENOSED TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. THE THRUWAY GUIDE WIRE WAS POSITIONED IN THE ARTERY AND THE 6.0X18MM EXPRESS VASCULAR SD STENT SYSTEM WAS THEN ADVANCED. THE STENT WAS DEPLOYED AND FLUOROSCOPY WAS PERFORMED. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. WHILE REMOVING THE THRUWAY GUIDE WIRE, THE J TIP BECAME CAUGHT ON THE DISTAL STENT STRUTS. THE PHYSICIAN PULLED ON THE WIRE, THE SPIRAL TIP STRETCHED AND ULTIMATELY THE STENT MIGRATED TO THE AORTIC ARTERY. ANOTHER PHYSICIAN ASSISTED AND THEY WERE ABLE TO RECOVER THE STENT UTILIZING A RETRIEVAL DEVICE LOOP. HOWEVER, THE PATIENT BECAME UNSTABLE, POSSIBLY DUE TO OTHER COMORBIDITIES, AND EXPIRED. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED U.S. DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74281 EXPRESS¿ VASCULAR SD CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74937918618150 15220699

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| R