BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT® ENDOPROSTHESIS

    MDR report key: 2222126 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03755
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AND THE RETURNED DEVICE WAS RETURNED WITHIN ANOTHER MANUFACTURERS' INTRODUCER SHEATH. IT WAS OBSERVED THAT THE OUTER SHEATH WAS FULLY RETRACTED AND THAT THE STENT WAS RELEASED BUT SITTING ON THE DISTAL TIP. FURTHER EXAMINATION NOTED THAT ONE OF THE DISTAL STENT WIRES WAS STICKING INTO THE DISTAL TIP AND SOME OF THE DISTAL STENT WIRES WERE UNCROSSED AND DAMAGED. THE STENT WAS REMOVED FROM THE TIP AND THE DELIVERY SYSTEM WAS CLOSED. THERE WAS NO ISSUE WITH THE MOVEMENT OF THE OUTER SHEATH. A TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE FOUND NO ISSUES. 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 STENTING TREATMENT PROCEDURE, A DEPLOYMENT AND REMOVAL DIFFICULTY ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VENA CAVA. THE 16X40/9 FR UNI PLUS 100CM WALLSTENT WAS USED DURING THE PROCEDURE AND EXPANDED UPON DEPLOYMENT. HOWEVER, THE STENT WAS NOT ABLE TO RELEASE FROM THE GUIDE CATHETER. THE PHYSICIAN HAD DIFFICULTIES REMOVING THE DEVICE ONCE THE STENT WAS DEPLOYED. THE STENT WOULD NOT COLLAPSE BACK DOWN FOR REMOVAL. AFTER CAREFUL MANIPULATION, THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE INTACT FROM THE VESSEL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A DEPLOYMENT AND REMOVAL DIFFICULTY ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VENA CAVA. THE 16X40/9 FR UNI PLUS 100CM WALLSTENT WAS USED DURING THE PROCEDURE AND EXPANDED UPON DEPLOYMENT. HOWEVER, THE STENT WAS NOT ABLE TO RELEASE FROM THE GUIDE CATHETER. THE PHYSICIAN HAD DIFFICULTIES REMOVING THE DEVICE ONCE THE STENT WAS DEPLOYED. THE STENT WOULD NOT COLLAPSE BACK DOWN FOR REMOVAL. AFTER CAREFUL MANIPULATION, THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE INTACT FROM THE VESSEL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT® ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965403310 13670756

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR