BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2428643 · Received January 23, 2012

    Report

    Report Number
    2954740-2011-00093
    Event Type
    Injury
    Date Received
    January 23, 2012
    Date of Event
    December 14, 2011
    Report Date
    December 14, 2011
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COIL WAS NOT RETURNED. MULTIPLE CONTRIBUTING FACTORS WERE FOUND THAT MAY HAVE PRODUCED THE MECHANICAL DETACHMENT OF THE COIL. THE FIRST CONTRIBUTING FACTOR MAY HAVE BEEN DUE TO THE BODY'S HIGH TORTUOSITY. THIS MAY HAVE PRODUCED TENSILE TRESSES TO WHERE THE COIL'S SOCKET RING IS SOLDERED TO THE PROXIMAL SECTION OF THE COIL. THIS MAY HAVE CAUSED THE BEGINNING OF A STRESS FRACTURE WHICH MAY HAVE BEEN DUCTILE IN NATURE REQUIRING EXTERNAL FORCE. THE SECOND CONTRIBUTING FACTOR MAY HAVE BEEN THE ANGLE BETWEEN THE DISTAL TIP OF THE MICROCATHETER, THE NECK OF THE ANEURYSM, AND ALSO THE STENT. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, "CAUTION: IF THE MICROCOIL IS POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER, A MICROCOIL MAY STRETCH OR BREAK AS IT IS BEING WITHDRAWN. BY REPOSITIONING THE DISTAL TIP OF THE CATHETER AT OR SLIGHTLY INSIDE THE OSTIUM OF THE ANEURYSM, THE MICROCOIL MAY BE MORE EASILY FUNNELED BACK INTO THE MICROCATHETER." WITHOUT THE RETURN OF THE SL-10 MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THIS COMPONENT CONTRIBUTED TO THE COMPLAINT EVENT. THE THIRD CONTRIBUTING FACTOR MAY HAVE BEEN DUE TO THE OVER FIFTEEN TIMES THAT THE COIL WAS REPOSITIONED AND MANIPULATED INSIDE AND OUTSIDE THE ANEURYSM. THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, CAUTION: IF REPOSITIONING OF THE MICROCOIL IS NECESSARY, CAREFULLY OBSERVE THE MOTION OF THE MICROCOIL IN RESPECT TO THE DPU WIRE WHILE RETRACTING THE MICROCOIL UNDER FLUOROSCOPY. IF THE MICROCOIL MOVEMENT IS NOT ONE-TO-ONE WITH THE DPU WIRE, OR IF REPOSITIONING IS DIFFICULT, THE MICROCOIL MAY HAVE BECOME STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD THE MICROCOIL SYSTEM.

    Description of Event or Problem · 1

    PER RECEIVED REPORT: IT WAS THE SIXTH (6TH) COIL PLACED THROUGH THE MICROCATHETER. AS THE PHYSICIAN REPOSITIONED THE COIL SEVERAL TIMES, THE COIL DETACHED PREMATURELY INTO THE ANEURYSM (NO DETACHMENT ATTEMPTS WERE MADE). THE MICROCATHETER WAS THEN WITHDRAWN BUT THE COIL REMAINED IN THE VESSEL. APPROX 8CM OF THE COIL WAS HANGING IN THE INTERNAL CAROTID ARTERY (ICA) OUTSIDE OF THE ANEURYSM. ATTEMPTS TO SNARE THE COIL WAS UNSUCCESSFUL AND CAUSED A COUPLE OF DISSECTIONS IN THE R ICA (RIGHT INTERNAL CAROTID ARTERY) SO A SECOND STENT WAS PLACED TO HOLD THE COIL IN PLACE WITHIN THE VESSEL. ADD'L REPORT RECEIVED ON (B)(6) 2012 STATED THAT THE PT HAD R MCA STROKE AND SPENT AT LEAST TWO WEEKS IN ACUTE REHAB CONTINUING HER OUTPATIENT PT/OT. SHE DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORPORATION G11658

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention