BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM

    MDR report key: 1792066 · Received August 10, 2010

    Report

    Report Number
    2134265-2010-03614
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 19, 2010
    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

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITHOUT THE STENT COMPONENT. EXAMINATION OF THE RETURNED DEVICE REVEALED NO DAMAGE WAS NOTED TO THE SHAFT OF THE DEVICE. THE BALLOON WAS FOLDED AND WRAPPED AROUND THE SHAFT OF THE DEVICE. A CLEAR IMPRESSION OF WHERE THE STENT WAS ORIGINALLY CRIMPED IS VISIBLE ON THE BALLOON MATERIAL. THE DEVICE WAS PASSED ALONG A 0.35" GUIDE WIRE WITH NO RESTRICTION NOTED. NO OTHER ISSUE WAS NOTED WITH THE DEVICE. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE PHYSICIAN WAS TREATING A 90% STENOSED LESION LOCATED IN THE MODERATELY TORTUOUS, 9MM IN DIAMETER, LEFT COMMON ILIAC ARTERY. THE LESION WAS PRE-DILATED WITH AN 8MM WANDA BALLOON CATHETER RESULTING IN 60% RESIDUAL STENOSIS. THIS 10.0X60X135 CM EXPRESS LD STENT WAS ADVANCED OVER A GUIDE WIRE AGAINST SOME RESISTANCE. PRIOR TO REACHING THE TARGET LESION, THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS) IN THE RIGHT COMMON ILIAC. THE STENT REMAINED ON THE GUIDE WIRE IN THIS LOCATION AND WAS DEPLOYED IN THE RIGHT EXTERNAL ILIAC WITH THE USE OF A DIFFERENT BALLOON CATHETER. THE PATIENT IS BEING BROUGHT BACK AT A LATER DATE TO TREAT THE TARGET LESION USING RETROGRADE ACCESS. THERE WERE NO FURTHER REPORTED PATIENT COMPLICATIONS. THE PATIENT STATUS IS LISTED AS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE PHYSICIAN WAS TREATING A 90% STENOSED LESION LOCATED IN THE MODERATELY TORTUOUS, 9MM IN DIAMETER, LEFT COMMON ILIAC ARTERY. THE LESION WAS PRE-DILATED WITH AN 8MM WANDA BALLOON CATHETER RESULTING IN 60% RESIDUAL STENOSIS. THIS 10.0X60X135 CM EXPRESS LD STENT WAS ADVANCED OVER A GUIDE WIRE AGAINST SOME RESISTANCE. PRIOR TO REACHING THE TARGET LESION, THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS) IN THE RIGHT COMMON ILIAC. THE STENT REMAINED ON THE GUIDE WIRE IN THIS LOCATION AND WAS DEPLOYED IN THE RIGHT EXTERNAL ILIAC WITH THE USE OF A DIFFERENT BALLOON CATHETER. THE PATIENT IS BEING BROUGHT BACK AT A LATER DATE TO TREAT THE TARGET LESION USING RETROGRADE ACCESS. THERE WERE NO FURTHER REPORTED PATIENT COMPLICATIONS. THE PATIENT STATUS IS LISTED AS STABLE. THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO AN APPROVED UNITED STATES 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 H74938162160130 0012878398

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention BALLOON CATHETER: 8MM WANDA