BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT-UNI ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYST

    MDR report key: 1202857 · Received October 17, 2008

    Report

    Report Number
    2134265-2008-03059
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE STENT REMAINS IMPLANTED AND THE DELIVERY SYSTEM WAS DISPOSED OF AT THE USER FACILITY AND WILL NOT BE RETURNED FOR EVAL, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT# 2134265-2008-03057, 2134265-2008-3058. IT WAS REPORTED THAT DURING A STENTING PROCEDURE, A BALLOON BREAK AND BALLOON DETACHMENT OCCURRED. THE 80-90% STENOSED LESION WAS LOCATED IN THE MIDLY TORTUOUS LEFT COMMON ILIAC VEIN. THE PROCEDURE WAS BEING PERFORMED FOR TREATMENT OF ILIAC VEIN COMPRESSION SYNDROME. THE LESION WAS NOT PRE-DILATED. THE WALLSTENT 22MM X 45MM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND SUCCESSFULLY DEPLOYED. THE XXL 18MM X 4MM BALLOON WAS ADVANCED FOR POST-DILATATION OF THE STENT. THE PHYSICIAN NOTED THAT THE BALLOON LENGTH WAS SHORTER THAN THE STENT LENGTH, THEREFORE, THE PHYSICIAN POST-DILATED THE PROXIMAL AND DISTAL STENT VIA SEPARATE "GENTLE" INFLATIONS TO UNK ATMS USING A 10CC SYRINGE, HOWEVER, THE BALLOON BROKE ON THE SECOND INFLATION. THE PHYSICIAN DREW NEGATIVE PRESSURE ON THE SYRINGE AT WHICH TIME BLOOD RETURN WAS NOTED IN THE LUMEN OF THE DEVICE WHICH THE PHYSICIAN FELT INDICATED A PINHOLE OR BALLOON LEAK DUE TO COMPROMISED BALLOON MATERIAL. THE DEVICE WAS REMOVED INTACT AND AN XXL 16MM X 4MM BALLOON WAS ADVANCED FOR POST-DILATATION OF THE STENT. THE BALLOON WAS INFLATED WITHOUT DIFFICULTY TWO TIMES UTILIZING A 10CC SYRINGE TO UNK ATMS, HOWEVER, FOLLOWING THE SECOND INFLATION THE BALLOON WAS UNABLE TO BE DEFLATED. THE PHYSICIAN ATTEMPTED TO APPLY NEGATIVE PRESSURE TO THE BALLOON WHILE GENTLY PULLING THE BALLOON BACK THROUGH THE SHEATH, HOWEVER, THE ENTIRE BALLOON DETACHED FROM THE SHAFT OF THE DEVICE. THE SHAFT WAS REMOVED INTACT WHILE THE DETACHED BALLOON REMAINED PARTIALLY DEFLATED INSIDE THE PT. THE PHYSICIAN ADVANCED A SNARE DEVICE AND WAS ABLE TO GRASP THE UNSPECIFIED GUIDE WIRE CONTAINING DETACHED BALLOON. THE PHYSICIAN WAS ABLE TO HOLD THE BALLOON IN THIS POSITION WHILE CONTRA-LATERAL ACCESS WAS OBTAINED. A SECOND SNARE DEVICE WAS ADVANCED FROM THE CONTRA-LATERAL GROIN IN AN ATTEMPT TO DEFLATE THE BALLOON BUT WAS UNSUCCESSFUL. THE PHYSICIAN WAS ABLE TO GRASP THE BALLOON WITH THE SNARE DEVICE CONTRA-LATERALLY. THE IPSI-LATERAL INTRODUCER SHEATH WAS REPLACED WITH AN UNSPECIFIED 18FR INTRODUCER SHEATH AND THE SECOND SNARE DEVICE WAS ADVANCED TO GRASP THE BALLOON FROM THE IPSI-LATERAL ACCESS SITE, HOWEVER, THE BALLOON WAS UNABLE TO BE REMOVED THROUGH THE SHEATH, DUE TO ITS PARTIAL INFLATION. THE PHYSICIAN REMOVED THE SHEATH AND BALLOON AS A UNIT AND IMMEDIATELY INSERTED A SECOND 18FR INTRODUCER SHEATH TO "PLUG THE HOLE". THE PHYSICIAN FELT THAT THIS MANEUVER CAUSED SOME DEGREE OF VASCULAR DAMAGE, HOWEVER, A VASCULAR CLOSURE WAS NOT NECESSITATED. THE PROCEDURE WAS COMPLETED AT THIS TIME WITH NO FURTHER INTERVENTION. THE PT IS REPORTEDLY "DOING WELL" AND THE PHYSICIAN INTENDED TO PERFORM AN ULTRASOUND OF THE PT'S GROIN A DAY OR SO FOLLOWING THE PROCEDURE TO CHECK FOR INSERTION SITE THROMBOSIS. IT WAS THE PHYSICIAN'S OPINION THAT THE WALLSTENT MAY HAVE CAUSED OR CONTRIBUTED TO BOTH BALLOON ISSUES DUE TO EACH BALLOON'S CONTACT WITH THE STENT'S EXPOSED BARE "FRINGE" WIRES LOCATED ON THE ENDS OF THE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT-UNI ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYST NA NIO BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention