BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS (TM) LD VASCULAR

    MDR report key: 2223080 · Received August 25, 2011

    Report

    Report Number
    2134265-2011-03655
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON CALCIFIED AND MODERATELY TORTUOUS RIGHT EXTERNAL ILIAC ARTERY. AS RESISTANCE WAS MET WHILE ADVANCING THE 7.0X40MM EXPRESS LD VASCULAR STENT SYSTEM TO THE LESION, EXCESSIVE FORCE WAS APPLIED. THE STENT DISLODGED FROM THE DELIVERY DEVICE, PRIOR TO REACHING THE LESION AND MIGRATED TO THE PROXIMAL TO THE STENOSIS. AS THEY WERE UNABLE TO GET THE STENT INTO THE SHEATH, THE 6FR NON BSC SHEATH WAS REPLACED WITH A 10FR SHEATH AND THE STENT WAS REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH A NON BSC STENT. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS (TM) LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162740750 14245946

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6FR PARENT PLUS INTRODUCER SHEATH| 0.035" RADIFOCUS GUIDE WIRE