BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM

    MDR report key: 2160076 · Received July 13, 2011

    Report

    Report Number
    2134265-2011-02750
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL AND TACTILE EXAMINATION OF THE DEVICE REVEALED NO DAMAGE WAS NOTED TO THE SHAFT OF THE DEVICE. THE STENT WAS STILL ON THE BALLOON IN THE CORRECT LOCATION. VISUAL EXAMINATION OF THE BALLOON AND STENT NOTED THAT THE PROXIMAL AND DISTAL END OF THE BALLOON WAS SLIGHTLY PUFFED, THIS MAY BE A RESULT OF THE PHYSICIAN ATTEMPTING TO INFLATE THE BALLOON DURING THE PROCEDURE. ONE OF THE STRUTS ON THE 8TH ROW PROXIMAL TO THE DISTAL EDGE OF THE STENT WAS LIFTED UP AND SOME OF THE STRUTS WERE MISALIGNED. A STRUT ON THE PROXIMAL END OF THE STENT WAS ALSO LIFTED UP AND MISALIGNED. THE DEVICE WAS PASSED OVER A BSC 0.035" GUIDEWIRE WITH NO RESTRICTIONS NOTED. THE DEVICE WAS ATTACHED TO ANOTHER MANUFACTURERS' INFLATION UNIT AND THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE (RBP) WITH NO LEAKS NOTED. A VACUUM WAS PULLED AND THE BALLOON DEFLATED WITH NO ISSUES. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. 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 COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A RENAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY STENTING TREATMENT PROCEDURE, A STENT DEPLOYMENT ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE RENAL. A NON-BSC .035" GUIDE WIRE AND GUIDE CATHETER WERE ADVANCED AND THEN THE 6.0X40X135 CM EXPRESS-VASCULAR LD STENT WAS POSITIONED AT THE TARGET LESION BUT WOULD NOT DEPLOY. THE PROCEDURE WAS NOT COMPLETED DUE TO NO ALTERNATIVE STENT AVAILABLE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE. 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 VASCULAR LD PREMOUNTED STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162640130 0013294955

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR .035" TERUMO GUIDE WIRE| CORDIS GUIDE CATHETER