BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON

    MDR report key: 20326338 · Received September 27, 2024

    Report

    Report Number
    2029214-2024-01692
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    March 15, 2014
    Report Date
    September 27, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: HUO, X., LI, Y., WU, Z., JIANG, Y., YANG, H., ZHAO, Y.. COMBINED TREATMENT OF BRAIN AVMS BY ONYX EMBOLIZATION AND GAMMA KNIFE RADIOSURGERY DECREASED HEMORRHAGE RISK DESPITE LOW OBLITERATION RATE. TURKISH NEUROSURGERY 1 2015. DOI:10.5 137/1019-5149.JTN.10708-14.1 A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. EARLIEST DATE OF ACCEPTANCE 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

    HUO X, LI Y, WU Z, JIANG Y, YANG H, ZHAO Y. COMBINED TREATMENT OF BRAIN AVMS BY ONYX EMBOLIZATION AND GAMMA KNIFE RADIOSURGERY DECREASED HEMORRHAGE RISK DESPITE LOW OBLITERATION RATE. TURKISH NEUROSURGERY. 2015;25(1):100-110. DOI:10.5137/1019-5149.JTN.10708-14.1 LITERATURE WAS REVIEWED REGARDING 'COMBINED TREATMENT OF BRAIN AVMS BY ONYX EMBOLIZATION AND GAMMA KNIFE RADIOSURGERY.' THE OBECTIVE OF THE STUDY WAS TO ANALYZE THE RADIOGRAPHIC AND CLINICAL OUTCOMES OF COMBINED ONYX EMBOLIZATION AND GAMMA KNIFE SURGERY (GKS) FOR CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS). THE TIME FRAME OF THIS STUDY WAS BETWEEN APRIL 2004 AND SEPTEMBER 2011. EIGHTY-SIX PATIENTS LEFT FOR ANALYSIS WERE 42 FEMALE (48.8%) AND 44 MALE (51.2%) WITH A MEAN AGE OF 27.8 YEARS. MULTIPLE MANUFACTURERS' DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX, MARATHON, ULTRAFLOW, AND APOLLO CATHETERS. ALL OF THE AVMS WERE EMBOLIZED WITH ONYX. THE FOLLOWING TECHNICAL ISSUES OCCURRED: -MICROCATHETER ENTRAPMENT IN 2 PATIENTS (2.3%) DEATHS OCCURRED IN THE STUDY POPULATION. THREE PATIENTS (3.5%) DIED OF AVM HEMORRHAGE AND 1 OF THEM WAS RUPTURED AVM. IN ONE PATIENT, THE NIDUS WAS PARTIALLY EMBOLIZED BY 1.4 ML ONYX AND RESIDUAL NIDUS WAS TREATED BY GKS 140 DAYS AFTER EMBOLIZATION. FOLLOW UP MRI SHOWED DECREASED VOLUME OF THE RESIDUAL NIDUS AND A SECOND GKS WAS PERFORMED 23 MONTHS AFTER THE FIRST GKS PROCEDURE. FOUR YEARS AFTER GKS, THE PATIENT SUDDENLY FELT HEADACHE AND CT SHOWED A HEMORRHAGE AND ANGIOGRAM SHOWED A SMALL RESIDUAL NIDUS WITH VERY THIN FEEDERS UNABLE TO BE EMBOLIZED. THE PATIENT WAS GIVEN EXPECTANT TREATMENT BY LOCAL HOSPITAL BUT FINALLY DIED OF MALIGNANT BRAIN EDEMA CAUSED BY HEMATOMA. AMONG PATIENT ADVERSE EVENTS INCLUDED: -EMBOLIZATION-RELATED COMPLICATIONS IN 13 PATIENTS (14.0%) TRANSIENT COMPLICATIONS: -HEMORRHAGE IN 4 PATIENTS (4.7%) -HEMIPARESIS IN 3 PATIENTS (3.5%) WITH FAVORABLE EVOLUTION -DEFECT OF VISUAL FIELD IN 1 PATIENT (1.2%) WITH COMPLETE RECOVERY -TEMPORARY APNEA IN 1 PATIENT (1.2%) -TRANSIENT DIPLOPIA IN 1 PATIENT (1.2%) PERMANENT COMPLICATIONS: -THROMBOEMBOLIC COMPLICATION IN 1 PATIENT (1.2%) CAUSING PERMANENT LEFT FOOT MUSCLE WEAKNESS (MRS 1) -FINAL CLINICAL EVALUATION WAS MRS SCORE OF 0¿1 IN 82 PATIENTS AND 2 IN 1 PATIENTS. SIGNIFICANT MODIFICATION OF THE CLINICAL STATUS (MRS 6) WAS OBSERVED IN 3 PATIENTS (3.5%). POST GAMMA KNIFE SURGERY (GKS) COMPLICATIONS: CLINICAL DETERIORATION IN 15 PATIENTS (17.4%), INCLUDING NEW HEADACHE IN 3 PATIENTS (3.5%) AND HEMORRHAGE IN 9 PATIENTS (10.6%) -INCREASED FREQUENCY OF SEIZURES IN 3 PATIENTS -IN 24 PATIENTS (52.2%), ONLY A PARTIAL OBLITERATION OF THE RESIDUAL AVM NIDUS WAS ACHIEVED AFTER 2 YEARS NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684356 MARATHON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-MARATHON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Required Intervention| S SEE H11...