BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC 10-3D/3D-SHAPE SYNERG DETECTION CIRCUIT

    MDR report key: 833583 · Received March 30, 2007

    Report

    Report Number
    6000078-2007-00100
    Event Type
    Injury
    Date Received
    March 30, 2007
    Date of Event
    March 6, 2007
    Report Date
    March 6, 2007
    Manufacturer
    BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION
    Product Code
    HCG
    PMA / PMN Number
    K991134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) # K001083.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNDERGOING COILING OF A 6MM ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY (ACA). AFTER POSITIONING A PRE-SHAPED 90 DEGREE ANGLE MICROCATHETER IN THE ANEURYSMAL SAC, THE COIL WAS REPOSITIONED TWO TIMES AND DEPLOYED WITHOUT DIFFICULTY. A FEW LOOPS OF THE COIL WERE NOTED TO BE PROTRUDING OUT OF THE ANEURYSM, SO THE PHYSICIAN DECIDED TO WITHDRAW THE COIL. UPON REMOVAL OF THE COIL (APPROXIMATELY 4-5 CM IN LENGTH) THE COIL UNEXPECTEDLY DETACHED. THE COIL WAS LOCATED IN THE CAROTID SIPHON AND THEN MIGRATED INTO THE HOMOLATERAL MIDDLE CEREBRAL ARTERY (MCA) OCCLUDING M1 AND M2 SEGMENTS OF THE SYLVIAN ARTERY. THE PROCEDURE WAS COMPLETED WITH A REMODELING TECHNIQUE AND USE OF OTHER SIMILAR COILS. THE PATIENT REPORTEDLY RECOVERED THREE HOURS FOLLOWING THE PROCEDURE. IT WAS ALSO REPORTED THAT "THE RECOVERY WILL BE POSSIBLE WITH THE USE OF A 0.010 EV3 GUIDEWIRE (SHAPED IN CURLY TAIL) AND ADDITION OF HIGH DOSE OF ANTI-PLATELET THERAPY. DURING THIS COIL RECOVERY, COIL WILL BREAK IN TWO AND A PART WILL MIGRATE IN THE INFERIOR RIGHT TEMPORAL ARTERY (SIMILAR RECOVERY TECHNIQUE USED). IT WAS NOT CLEAR WHETHER THIS INTERVENTION HAD ALREADY TAKEN PLACE OR WOULD BE PERFORMED AT A LATER DATE. PATIENT IS CURRENTLY ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC 10-3D/3D-SHAPE SYNERG DETECTION CIRCUIT (84 HCG) DETACHABLE COIL. HCG BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION 345615-4 8917442

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention THE DAY BEFORE THE PROCEDURE THE PT TOOK 150 MG| ASPIRIN DURING THE PROCEDURE| HEPARIN DURING THE PROCEDURE.| CLOPIDOGREL