BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARKSMAN

    MDR report key: 19214168 · Received April 30, 2024

    Report

    Report Number
    2029214-2024-00799
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    January 1, 2020
    Report Date
    April 30, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. G2: CITATION: AUTHORS: MEMON M, EZZELDIN M, BISWAS A, AHMAD R, NISAR T, SINGLA A, MUHAMMAD N, SHALTONI H, KAN P, ZAIDAT O, KHANDELWAL P. NOVEL TECHNIQUE OF STENT PLACEMENT VIA GATEWAY BALLOON IN INTRACRANIAL ATHEROSCLEROSIS-ASSOCIATED LARGE VESSEL OCCLUSION. JOURNAL OF NEUROIMAGING 33:773¿780 2023. 10.1111/JON.13139 NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING A NOVEL TECHNIQUE OF STENT PLACEMENT VIA GATEWAY BALLOON IN INTRACRANIAL ATHEROSCLEROSIS-ASSOCIATED LARGE VESSEL OCCLUSION. PRELIMINARY EXPERIENCE SUGGESTS POSSIBLE SAFETY AND FEASIBILITY OF DEPLOYING NEUROFORM ATLAS STENT THROUGH A COMPATIBLE GATEWAY BALLOON MICROCATHETER WITHOUT THE NEED FOR ICH-ASSOCIATED MICROCATHETER EXCHANGE., USING MARKSMAN, REACT, AND SOLITAIRE. FURTHER STUDIES WITH LONG-TERM CLINICAL AND ANGIOGRAPHIC FOLLOW-UP ARE WARRANTED TO CORROBORATE THE INITIAL FINDINGS. ADVERSE EVENTS INCLUDED PATIENTS WITH VESSEL DISSECTION, GROIN HEMATOMA, INTRACRANIAL CEREBRAL HEMORRHAGE, AND DEATH. ONE PATIENT REQUIRED BALLOON ANGIOPLASTY FOR THE SOLITAIRE STENT.   1. TWO PATIENTS WERE FOUND TO HAVE VESSEL DISSECTION IN THE STENTED SEGMENT CLASSIFIED AS BIFFL GRADE 2. 2. THREE PATIENTS HAD DEVELOPED GROIN HEMATOMA THAT RESOLVED WITH CONSERVATIVE MANAGEMENT. 3. ONE PATIENT HAD ICH POST-OP THAT WAS ASYMPTOMATIC. THIS WAS DEEMED A HEMORRHAGIC INFARCTION (HI) 2 AS PER ECASS 3 ICH CLASSIFICATION. 4. 4 PATIENTS (18%) DIED WITHIN 90 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143520 MARKSMAN CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-MARKSMAN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention