BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS¿ LD VASCULAR

    MDR report key: 3103141 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03283
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT THE TIME OF EVENT : OVER 18 YEARS. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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, STENT DAMAGE AND STENT MOVED ON BALLOON OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA LEFT INGUINAL REGION WITH A 6F 90CM NON-BSC SHEATH. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS LEFT SUBCLAVIAN ARTERY. A 4MM MUSTANG BALLOON CATHETER WAS ADVANCED OVER A NON-BSC GUIDEWIRE AND WAS USED TO PRE-DILATE THE LESION. A 8.0X30X135CM EXPRESS LD VASCULAR STENT DELIVERY SYSTEM (SDS) WAS USED TO TREAT THE LESION. DURING THE ATTEMPT TO CROSS THE LESION, THE COMPLAINT DEVICE WAS STUCK AT THE OSTIAL PORTION OF THE VESSEL. THEY TRIED TO FORCE THIS DEVICE TO ADVANCE INTO THE LESION BUT THE STENT WAS MOVED A LITTLE. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH DILATION USING AN UNKNOWN 6MM BALLOON AND THE IMPLANT OF ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. THIS DEVICE IS ONLY OUD APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204132 EXPRESS¿ LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC NIO BOSTON SCIENTIFIC - GALWAY H74938162830130 14898430

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH:6FDESTINATION| INFLATION DEVICE:EVEREST| BALLOON CATHETER:MUSTANG| GUIDEWIRE:RADIFOCUS035