BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS¿ LD VASCULAR

    MDR report key: 3013123 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01675
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT COMMON FEMORAL ARTERY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS LEFT COMMON ILIAC ARTERY. THE NON BSC GUIDE WIRE CROSSED AND THE 7.0 X 30MM X 135CM EXPRESS VASCULAR LD STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH A NON BSC INTRODUCER SHEATH, BUT WAS UNABLE TO CROSS THE LESION. AFTER REMOVAL OF THE SDS FROM THE PATIENT IT WAS NOTED THAT THE DISTAL PORTION OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116477 EXPRESS¿ LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162730130 15519494

    Patients

    Seq Age Sex Outcome Treatment
    1 .035 RADIFOCUS TERUMO: GUIDE WIRE| ENCORE: INFLATION DEVICE| 6F DESTINATION TERUMO: INTRODUCER SHEATH