BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARKSMAN

    MDR report key: 21826586 · Received April 11, 2025

    Report

    Report Number
    2029214-2025-00963
    Event Type
    Death
    Date Received
    April 11, 2025
    Date of Event
    November 2, 2023
    Report Date
    April 11, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    K091559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION:JI, Z., HE, C., LI, J., GENG, J., HU, P., LI, G., <(>&<)> ZHANG, H. (2023). SAFETY AND EFFICACY OF LOW-PROFILE BRAIDED STENTS VERSUS FLOW DIVERTERS IN THE RECONSTRUCTIVE TECHNIQUE IN THE TREATMENT OF PATIENTS WITH VERTEBROBASILAR DOLICHOECTASIA ANEURYSMS: A COHORT OF 47 PATIENTS WITH LONG-TERM FOLLOW-UP. ORIGINAL RESEARCH NEUROINTERVENTION, 45(2), 176¿182. HTTPS://DOI.ORG/10.3174/AJNR.A8091. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT 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 SAFETY AND EFFICACY OF LOW-PROFILE BRAIDED STENTS VERSUS FLOW DIVERTERS IN THE RECONSTRUCTIVE TECHNIQUE IN THE TREATMENT OF PATIENTS WITH VERTEBROBASILAR DOLICHOECTASIA ANEURYSMS: A COHORT OF 47 PATIENTS WITH LONG-TERM FOLLOW-UP. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: 5F OR 6F NAVIEN INTERMEDIATE CATHETER, MARKSMAN, PHENOM 27, PIPELINE EMBOLIZATION DEVICE. DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. THE CAUSES OF DEATH WERE: TWO PATIENTS DIED OF BRAINSTEM FUNCTION FAILURE RESULTING FROM BRAINSTEM INFARCTION, 2 PATIENTS DIED OF INTRACEREBRAL HEMORRHAGE RESULTING FROM THROMBOLYSIS FROM BRAINSTEM INFARCTION, AND 1 DIED DIRECTLY FROM INTRACRANIAL HEMORRHAGE. ANOTHER 2 PATIENTS DIED OF UNCORRELATED HEART FAILURE AND PNEUMONIA. AMONG ALL PATIENTS ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: TWO PATIENTS DIED OF BRAINSTEM FUNCTION FAILURE RESULTING FROM BRAINSTEM INFARCTION. TWO PATIENTS DIED OF INTRACEREBRAL HEMORRHAGE RESULTING FROM THROMBOLYSIS FROM BRAINSTEM INFARCTION. ONE PATIENT DIED DIRECTLY FROM INTRACRANIAL HEMORRHAGE. FOUR SURVIVING PATIENTS WERE LOST TO RADIOLOGIC IMAGING FOLLOW-UP DUE TO POOR STATUS. SIGNIFICANTLY HIGHER RATES OF COMPLETE OCCLUSION OF VERTEBROBASILAR DOLICHOECTASIA ANEURYSMS (VBDA) WERE SHOWN IN THE FLOW DIVERTER (FD) GROUP THAN IN THE LOW-PROFILE BRAIDED STENT (LPBS) GROUP (LPBS, 10%, VERSUS FD, 41.2%; P ¼ .028). 12 PATIENTS (60%) IN THE LPBS GROUP AND 7 PATIENTS (41.2) IN THE FD GROUP EXPERIENCED NEAR-COMPLETE OCCLUSION. 6 PATIENTS (30%) IN THE LPBS GROUP AND 3 PATIENTS (17.6%) IN THE FD GROUP EXPERIENCED INCOMPLETE OCCLUSION. 11 PATIENTS (44%) IN THE LPBS GROUP AND 9 PATIENTS (40.9%) IN THE FD GROUP EXPERIENCED POOR CLINICAL OUTCOME (MRS 2). 12 PATIENTS (48%) IN THE LPBS GROUP EXPERIENCED AGGRAVATED SYMPTOMS. 8 PATIENTS (36.4%) IN THE FD GROUP EXPERIENCED AGGRAVATED SYMPTOMS. PROCEDURAL COMPLICATIONS INCLUDED ISCHEMIC COMPLICATIONS, WHICH ACCOUNTED FOR MOST DEFICITS, AND HEMORRHAGIC COMPLICATIONS. THERE WERE NEW NEUROLOGIC DEFICITS DUE TO PROCEDURAL COMPLICATIONS: HEMORRHAGIC; ONE PATIENT (4%) IN THE LPBS GROUP, 2 PATIENTS (9.1%) IN THE FD GROUP. ISCHEMIC: 5 PATIENTS (20%) IN THE LPBS GROUP, 9 PATIENTS (40.9%) IN THE FD GROUP. 6 (24%) OF PATIENTS IN THE LBS GROUP EXPERIENCED MILD-TO-SEVERE-DISABILITY, 6 (27.3%) IN THE FD GROUP. 10 PATIENTS (50%) IN THE LPBS AND 5 PATIENTS (29.4%) IN THE FD GROUP EXPERIENCED PROGRESSION OF MASS EFFECT. ADDITIONALLY, THE STUDY NOTED THAT BRAINSTEM COMPRESSION RESULTING FROM VBDAS POSED A SIGNIFICANT THERAPEUTIC CHALLENGE, AND WHILE NO SIGNIFICANT DIFFERENCES WERE SHOWN, THE LPBS PROVED TO BE LESS EFFECTIVE IN PREVENTING PROGRESSION OF MASS EFFECT. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349347 MARKSMAN CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-MARKSMAN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Death