BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS¿ LD VASCULAR

    MDR report key: 3062527 · Received April 17, 2013

    Report

    Report Number
    2134265-2013-02481
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 20, 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 MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AND STENT DAMAGE WAS NOTED ALONG WITH THE STENT HAVING MOVED ON THE BALLOON. THE DEVICE WAS RETURNED ON A 7 FRENCH SHEATH AND THERE WAS EVIDENCE THAT POSITIVE PRESSURE WAS APPLIED AS A PROXIMAL PORTION OF THE STENT MEASURING 16MM HAD EXPANDED. IT IS NOTED THAT THE STENT MOVED FORWARD TOWARDS THE DISTAL TIP AND THERE WAS EVIDENCE OF STENT DAMAGE AT APPROXIMATELY 19MM PROXIMAL TO DISTAL END. THERE IS NO SHAFT DAMAGE AND NO ISSUE WITH THE TIP. 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

    REPORTABLE BASED ON ANALYSIS. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, FAILURE TO CROSS THE LESION OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT INGUINAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT COMMON ILIAC ARTERY. THIS 9.0 X 60 X 75CM EXPRESS - VASCULAR LD STENT BALLOON CATHETER WAS SELECTED AND ADVANCED TO THE LESION BUT WAS UNABLE TO CROSS THE LESION. IT WAS NOTED THAT THE PHYSICIAN ATTEMPTED TO DEPLOY THE EXPRESS STENT SEVERAL TIMES. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT WITH NO RESISTANCE. THE PROCEDURE WAS CONTINUED WITH ANOTHER OF THE SAME EXPRESS - VASCULAR LD STENT BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT WAS PARTIALLY EXPANDED AND THE STENT WAS MOVED ON BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165400 EXPRESS¿ LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162960750 0014516308

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: 0.035 X 180CM (TORAY)| INTRODUCER SHEATH: 7FR 10CM SHEATH (MEDIKIT)