BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC 10-SOFT 2D SR / 2-DIAMETER STRETCH RES.

    MDR report key: 1013348 · Received March 13, 2008

    Report

    Report Number
    2939204-2008-00087
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    October 31, 2007
    Report Date
    February 15, 2008
    Manufacturer
    NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    PMA / PMN Number
    K001083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MCA (MIDDLE CEREBRAL ARTERY) WAS OCCLUDED. THE PT CURRENTLY HAS LEFT INCOMPLETE HEMIPARESIS, WITH NORMAL COGNITIVE FUNCTION, CONVERSATION AND COMMUNICATION. RESPONSES TO ALL REQUESTS FOR ADD'L INFO HAVE NOT BEEN RECEIVED TO DATE. PROCEDURE IMAGES REQUESTED AND RECEIVED WERE REVIEWED BY AN ON-SITE MEDICAL PROFESSIONAL. THE IMAGES CONFIRMED THE REPORTED EVENT; HOWEVER, NO CONCLUSION COULD BE DRAWN. THE RISK OF THE REPORTED EVENT IS NOTED IN THE DEVICE DIRECTIONS FOR USE (DFU). PER THE DFU: "DUE TO THE DELICATE NATURE OF THE GDC COILS, THE TORTUOUS VASCULAR PATHWAYS WHICH LEAD TO CERTAIN ANEURYSMS AND VESSELS, AND THE VARYING MORPHOLOGIES OF INTRACRANIAL ANEURYSMS, A COIL MAY OCCASIONALLY STRETCH WHILE BEING MANEUVERED. STRETCHING IS A PRECURSOR TO POTENTIAL MALFUNCTIONS, SUCH AS COIL BREAKAGE AND MIGRATION." THE DFU PRECAUTIONS "IF GDC REPOSITIONING IS NECESSARY, TAKE SPECIAL CARE TO RETRACT COIL UNDER FLUOROSCOPY IN A ONE-TO-ONE MOTION WITH THE DELIVERY WIRE. IF THE COIL DOES NOT MOVE WITH A ONE-TO-ONE MOTION, OR REPOSITIONING IS DIFFICULT, THE COIL HAS BEEN STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD BOTH THE CATHETER AND COIL." BASED ON THE INFO KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE.

    Description of Event or Problem · 1

    THE PROCEDURE WAS AN ANEURYSM COILING OF THE RIGHT POSTERIOR COMMUNICATING ARTERY. THE PT HAD A 3X6MM ANEURYSM SHAPED LIKE AN EIGHT (HUNT & HESS SCALE 2). THE PHYSICIAN IMPLANTED THE FIRST TWO COILS WITHOUT PROBLEMS IN THE DISTAL PART OF THE 8-SHAPE. "THE THIRD COIL WAS PLACED PARTIALLY IN THE DISTAL PART AND PARTIALLY IN THE PROXIMAL PART. TWO LOOPS OF THIS COIL WERE FORMING AN INITIAL CAGE. WHILE PUSHING THE FOURTH COIL (SUBJECT DEVICE) INTO THE ANEURYSM SUDDENLY THERE WAS A "NO PUSH - NO PULL" SITUATION. THE COIL COULD NOT BE PUSHED INTO THE ANEURYSM AND COULD NOT BE REMOVED OUT OF THE ANEURYSM." THE PHYSICIAN "...CAREFULLY TRIED TO PULL BACK THE MICROCATHETER." DURING THIS MANEUVER, "...THE COIL WAS DEPARTED FROM THE DELIVERY WIRE AND JUMPED IN THE ICA (INTERNAL CAROTID ARTERY) CARRYING AWAY THE LOOPS OF THE THIRD COIL IN THE PROXIMAL PART OF THE ANEURYSM. PT HAD TO BE OPERATED BUT THE RIGHT MCA (MIDDLE CEREBRAL ARTERY) WAS COMPLETELY OCCLUDED". THE MCA OCCLUSION WAS CAUSED BY "VASOSPASM SECONDARY TO COIL MIGRATION IN M1 FOLLOWED BY THROMBOSIS..." THE FOURTH COIL ENDED UP IN PROXIMAL M1; THE THIRD COIL CONNECTED TO THE FOURTH COIL HAD ONE STRETCHED LOOP IN THE A1 - THE OTHER LOOPS REMAINED WITHIN THE ANEURYSM. IN RESPONSE, SUCCESSFUL COIL EXTRACTION, CLIPPING AND DECOMPRESSION CRANIOTOMY WERE PERFORMED. CURRENT PT CONDITION WAS REPORTED TO BE "LEFT INCOMPLETE HEMIPARESIS. WALKING WITH DEVICE. NORMAL COGNITIVE FUNCTION. NORMAL CONVERSATION AND COMMUNICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 10-SOFT 2D SR / 2-DIAMETER STRETCH RES. HCG-DEVICE, NEUROVASCULAR EMBOLIZATION HCG NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP. 344306-SR4 0008603458

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R TRACKER MICROCATHETER (BSC DEVICES)| 1 COIL (3RD COIL| 2 GDC COILS| POWER SUPPLY