BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON

    MDR report key: 12849199 · Received November 19, 2021

    Report

    Report Number
    2029214-2021-01508
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    January 1, 2015
    Report Date
    November 19, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. EV3 NEUROVASCULAR
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEE ASSOCIATED EVENT INFORMATION REPORTED IN REGULATORY REPORT 3007170829-2021-00027. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MAUS V, DRESCHER F, GOERTZ L, WEBER A, WEBER W, FISCHER S. ENDOVASCULAR TREATMENT OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS: A GERMAN SINGLE-CENTER EXPERIENCE. KARGER OPEN ACCESS (2020). 10:84¿93. DOI:10.1159/000509455. MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH TRANSVENOUS EMBOLIZATION. THE PURPOSE OF THIS ARTICLE WAS TO PRESENT SINGLE-CENTER EXPERIENCE OF PATIENTS SUFFERING FROM INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS (DAVFS) TREATED WITH TRANSARTERIAL AND/OR TRANSVENOUS EMBOLIZATION WITH CURATIVE INTENT, AND ALSO DISCUSS THE CURRENT ENDOVASCULAR TREATMENT OPTIONS. THE AUTHORS REVIEWED 50 PATIENTS WITH 93 TREATMENTS FOR DAVFS USING NAVIEN INTERMEDIATE CATHETERS, MARATHON MICROCATHETERS, AND ONYX, AMONG OTHER MANUFACTURER PRODUCTS. OF THE 50 PATIENTS, THE AVERAGE AGE WAS 61 YEARS, 17 WERE FEMALE AND 33 WERE MALE. THE MOST COMMON SYMPTOM WAS PULSATILE TINNITUS IN 17 PATIENTS (34%). THE MOST FREQUENT LOCATION OF THE DAVF WAS THE TRANSVERSE-SIGMOID SINUS (40%). THIRTY-SIX FISTULAS (72%) HAD CORTICAL VENOUS REFLUX. NONADHESIVE AND ADHESIVE LIQUID AGENTS WERE USED IN 92% AS A SINGLE MATERIAL OR IN COMBINATION. COMPLETE OCCLUSION (CO) WAS ACHIEVED IN 48 PATIENTS (96%). IN 28 INDIVIDUALS (56%), ONLY 1 PROCEDURE WAS NECESSARY. NONADHESIVE LIQUID AGENTS WERE EXCLUSIVELY USED IN 14 PATIENTS (28%) WITH CO ATTAINED IN EVERY CASE. FOR CO OF TENTORIAL DAVFS, MULTIPLE SESSIONS WERE MORE OFTEN REQUIRED THAN AT THE OTHER LOCATIONS (55 VS. 14%, P = 0.0051). AMONG 93 PROCEDURES, THE OVERALL COMPLICATION RATE WAS 3%. THE PROCEDURE-RELATED MORTALITY RATE WAS 0%. ENDOVASCULAR TREATMENT OF INTRACRANIAL DAVFS IS FEASIBLE, SAFE, AND EFFECTIVE WITH HIGH RATES OF CO. IN ALL PATIENTS, A COMPLETE RECOVERY FROM PULSATILE TINNITUS OR OCULAR SYMPTOMS WAS ACHIEVED DUE TO COMPLETE FISTULA CLOSURE. IN MORE THAN HALF OF THE PATIENTS, THE DAVF WAS COMPLETELY OCCLUDED AFTER A SINGLE PROCEDURE. HOWEVER, IN TENTORIAL DAVFS, MULTIPLE SESSIONS WERE MORE OFTEN REQUIRED. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE NAVIEN, MARATHON, OR ONYX. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: TINNITUS, HEADACHE, SEIZURE, DOUBLE VISION, INTRACRANIAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745764 MARATHON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. EV3 NEUROVASCULAR UNK-NV-MARATHON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other