BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARKSMAN

    MDR report key: 7055066 · Received November 22, 2017

    Report

    Report Number
    2029214-2017-01300
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    October 27, 2017
    Report Date
    December 19, 2017
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    KRA
    UDI-DI
    00847536026261
    PMA / PMN Number
    K091559
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. ATTEMPTS HAVE BEEN MADE TO INQUIRE ABOUT THE STATUS OF THE DEVICE AND RECEIVED INFORMATION THAT THEY FACILITY HAS NOT RELEASED THE DEVICE. REGARDING THE LOT NUMBER THAT WAS PROVIDED BY THE INITIAL REPORTER AND THE FDA INQUIRY, IT WAS NOT A VALID NUMBER. SENT CORRESPONDENCE REQUESTING CORRECT LOT NUMBER. AWAITING RESPONSE AND RETURN OF DEVICE. ONCE DEVICE IS RECEIVED, EVALUATION WILL BE PERFORMED AND SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPDATED: LOT#: 213406390 CONFIRMED DEVICE LOT NUMBER. ALSO RECEIVED ADDITIONAL INFORMATION STATING THAT THE MARKER BAND INCLUDING THE DISTAL TIP SEPARATED FROM THE MARKSMAN MICROCATHETER AND REMAINED IN THE PATIENT. THE TOTAL LENGTH OF THE MARKER BAND (DISTAL TIP) WAS APPROXIMATELY 1MM. THE MARKER BAND AND DISTAL TIP IS ESSENTIALLY ONE PIECE THAT IS ABOUT 1MM IN LENGTH. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AS IT IS STILL KEPT BY THE FACILITY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN ACUTE ISCHEMIC STROKE, RESISTANCE WAS FELT AS THE STENT WAS BEING DELIVERED. ONCE THE STENT WAS RETRIEVED, FOLLOW UP IMAGING REVEALED THAT THE DISTAL MARKER BAND OF THE MICROCATHETER HAD SEPARATED AND MIGRATED TO THE POSTERIOR COMMUNICATING ARTERY (PCOM). PRIOR TO THE EVENT, THE MICROCATHETER WAS ADVANCED INTO THE LEFT MIDDLE CEREBRAL ARTERY (MCA) OVER A SYNCHRO WIRE. THE PATIENT¿S VASCULATURE WAS SEVERE IN TORTUOSITY. THE STENT WAS ADVANCED THROUGH THE MICROCATHETER AND UNSHEATHED ONCE IN THE DESIRED LOCATION. RESISTANCE WAS FELT IN THE DISTAL PORTION OF THE MICROCATHETER AS THE STENT WAS BEING DELIVERED. THE PLATINUM MARKER BAND WAS VISUALIZED INTACT BEFORE RETRIEVING THE STENT. ONCE THE STENT WAS RETRIEVED, FOLLOW UP IMAGING WAS PERFORMED AND THE PHYSICIAN NOTICED THE MARKER BAND OF THE CATHETER HAD BECOME SEPARATED AND WAS NOW IN THE LEFT PCOM ARTERY. THERE WERE TWO PASSES MADE WITH THE STENT, BUT THE MARKER BAND SEPARATED AFTER THE FIRST PASS. THERE WAS NO WAY TO RETRIEVE THE MARKER BAND SO THE PROCEDURE WAS ABORTED. THE PATIENT DID NOT HAVE ANY SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED AND THERE WILL BE NO ATTEMPTS TO REMOVE THE MARKER BAND. RECEIVED INQUIRY FROM FDA WITH ADDITIONAL INFORMATION REGARDING THE SAME EVENT WITH SAME LOT NUMBER PROVIDED IN INITIAL REPORT; HOWEVER, TWO THE MENTIONED TWO IDENTICAL DEVICES WITH IDENTICAL PROBLEMS. CONTACTED THE REP AND CONFIRMED THAT ONLY ONE MICROCATHETER WAS INVOLVED AND HAS NOT YET BEEN RELEASED FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834162 MARKSMAN CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR FA-55150-1030 213406390 00847536026261

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability