BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX CATHETER

    MDR report key: 13565390 · Received February 19, 2022

    Report

    Report Number
    2029214-2022-00240
    Event Type
    Injury
    Date Received
    February 19, 2022
    Date of Event
    January 1, 2011
    Report Date
    February 19, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GOERTZ L, LIEBIG T, SIEBERT E, PFLAEGING M, FORGRIG R, PENNIG L, SCHLAMANN M, DORN F, KABBASCH C. INTRASACCULAR FLOW DISRUPTION WITH THE WOVEN ENDOBRIDGE FOR NARROW-NECKED ANEURYSMS: A SAFETY AND FEASIBILITY STUDY. WORLD NEUROSURGERY. JULY 2021, 151: E278-E285,. DOI: 10.1016/J.WNEU.2021.04.018. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    GOERTZ L, LIEBIG T, SIEBERT E, PFLAEGING M, FORGRIG R, PENNIG L, SCHLAMANN M, DORN F, KABBASCH C. INTRASACCULAR FLOW DISRUPTION WITH THE WOVEN ENDOBRIDGE FOR NARROW-NECKED ANEURYSMS: A SAFETY AND FEASIBILITY STUDY. WORLD NEUROSURGERY. JULY 2021, 151: E278-E285,. DOI: 10.1016/J.WNEU.2021.04.018. MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH NAVIEN CATHETER. THE WOVEN ENDOBRIDGE (WEB) RECEIVED U.S. FOOD AND DRUG ADMINISTRATION APPROVAL FOR ENDOVASCULAR TREATMENT OF WIDE-NECKED BIFURCATION ANEURYSMS. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE FEASIBILITY, SAFETY, AND EFFICACY OF THE WEB FOR TREATMENT OF NARROW-NECKED ANEURYSMS. THE AUTHORS REVIEWED 17 PATIENTS WITH ANEURYSMS. OF THE 17 PATIENTS, THE AVERAGE AGE WAS 55 YEARS, 10 WERE FEMALE AND 7 WERE MALE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE NAVIEN. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: 1. IN 2 PATIENTS, POSTINTERVENTIONAL MAGNETIC RESONANCE IMAGING SHOWED SILENT THROMBOEMBOLIC CEREBRAL INFARCTION WITHOUT CORRELATING NEUROLOGICAL DEFICITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2407715 REFLEX CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RFX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other