BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET 360 SOFT 5 MM X 10 CM

    MDR report key: 6191589 · Received December 20, 2016

    Report

    Report Number
    3008881809-2016-00323
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    December 6, 2016
    Report Date
    February 27, 2017
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K102672
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE, PHYSICAL AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION CURRENTLY AVAILABLE THE EXACT CAUSE OF THE DEVICE ISSUE CANNOT BE DETERMINED. HOWEVER, THE VESSEL THROMBOSIS AND STROKE ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS WAS ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COIL WAS PLACED INSIDE THE POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM AND DETACHED, THE PUSHER WIRE WAS PULLED BACK. HOWEVER, THE PHYSICIAN NOTED THAT 3CM OF THE MAIN COIL CAME BACK IN TO THE MICROCATHETER; THE MICROCATHETER ACCESS WAS LOST AND 3-4CM OF COIL WAS PROTRUDED OUT OF THE ANEURYSM. THEN THE BLOOD FLOW DISLODGED THE ENTIRE COIL IN TO THE MIDDLE CEREBRAL ARTERY (MCA. THE COIL WAS SAFELY REMOVED USING A SNARE. FIVE MORE COILS WERE SUCCESSFULLY IMPLANTED INTO THE ANEURYSM AND THE PROCEDURE WAS COMPLETED. THE PATIENT DEVELOPED A MINOR STROKE AND THE PHYSICIAN BELIEVED THAT THE PATIENT SHOULD RECOVER. THE PHYSICIAN STATED THAT IT WAS NOT CLEAR WHAT THE CAUSE OF THE STROKE WAS: THE COIL MIGRATION OR THE THROMBUS NOTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COIL WAS PLACED INSIDE THE POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM AND DETACHED, THE PUSHER WIRE WAS PULLED BACK. HOWEVER, THE PHYSICIAN NOTED THAT 3CM OF THE MAIN COIL CAME BACK IN TO THE MICROCATHETER; THE MICROCATHETER ACCESS WAS LOST AND 3-4CM OF COIL WAS PROTRUDED OUT OF THE ANEURYSM. THEN THE BLOOD FLOW DISLODGED THE ENTIRE COIL IN TO THE MIDDLE CEREBRAL ARTERY (MCA. THE COIL WAS SAFELY REMOVED USING A SNARE. FIVE MORE COILS WERE SUCCESSFULLY IMPLANTED INTO THE ANEURYSM AND THE PROCEDURE WAS COMPLETED. THE PATIENT DEVELOPED A MINOR STROKE AND THE PHYSICIAN BELIEVED THAT THE PATIENT SHOULD RECOVER. THE PHYSICIAN STATED THAT IT WAS NOT CLEAR WHAT THE CAUSE OF THE STROKE WAS: THE COIL MIGRATION OR THE THROMBUS NOTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841578 TARGET 360 SOFT 5 MM X 10 CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R EXCELSIOR SL-10 (STRYKER)