BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 24865745 · Received April 13, 2026

    Report

    Report Number
    2029214-2026-00667
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    June 3, 2025
    Report Date
    April 13, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. REPORTED EVENT DATE IS DATE ARTICLE WAS INITIALLY PUBLISHED ONLINE. 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

    ROY, J. M., MUSMAR, B., KODURI, S., BALDARI, A., SOKOL, Z., AMARAVADI, C., KARADIMAS, S., KOZAK, O., MACKENZIE, L., SCHMIDT, R. F., GHOSH, R., TJOUMAKARIS, S. I., GOOCH, M. R., ZARZOUR, H., ROSENWASSER, R. H., <(>&<)> JABBOUR, P. M. (2026). FLOW DIVERSION IN PATIENTS WITH CONCURRENT ANTICOAGULATION: MULTICENTER EXPERIENCE AND SYSTEMATIC REVIEW OF LITERATURE. OPERATIVE NEUROSURGERY (HAGERSTOWN, MD.), 30(2), 242¿249. HTTPS://DOI.ORG/10.1227/ONS.0000000000001660 MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A RETROSPECTIVE MULTI-CENTER STUDY OF PATIENT ON CONCURRENT ORAL ANTICOAGULATION BEFORE FLOW DIVERTER TREATMENT OF INTRACRANIAL ANEURYSMS BETWEEN JANUARY 2018 AND JANUARY 2024. A TOTAL OF 19 PATIENTS UNDERWENT FLOW DIVERTER TREATMENT OF 20 ANEURYSMS WHILE ON ANTICOAGULANTS. MULTIPLE MANUFACTURERS' DEVICES WERE USED; 9 PATIENTS IN THE STUDY GROUP WERE TREATED WITH PIPELINE EMBOLIZATION DEVICES, BOTH PIPELINE FLEX AND PIPELINE FLEX WITH SHIELD WERE USED. NO DEVICES MALFUNCTION WAS REPORTED IN THE ARTICLE. SERIOUS ADVERSE EVENTS REPORTED IN THE ARTICLE REGARDING PATIENTS TREATED WITH PIPELINE WHICH DID NOT RESULT IN DEATH INCLUDED: - A 75 YEAR OLD FEMALE PATIENT HAD A PIPELINE FLEX WITH SHIELD STENT IMPLANTED TO TREAT A POSTERIOR COMMUNICATING ARTERY (PCOM) UNRUPTURED SACCULAR ANEURYSM THAT MEASURED 3.7 X 2.8 X 4.4MM. IT WAS REPORTED THAT THE PATIENT/ANEURYSM REQUIRED RETREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161628 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-PED2 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention