BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 23341404 · Received October 20, 2025

    Report

    Report Number
    2029214-2025-02240
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    May 22, 2025
    Report Date
    October 20, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: AKIYAMA, R., ISHII, A., CHIHARA, H., SAKAI, C., KIKUCHI, T., OKAWA, M., IKEDO, T., TAKADA, S., MATSUKAWA, S., ARAKAWA, Y.. PIPELINE SHIELD REDUCES DIFFUSION-WEIGHTED IMAGINGDETECTED ISCHEMIA AFTER INTRACRANIAL ANEURYSM TREATMENT COMPARED WITH PIPELINE FLEX: A PROPENSITY SCORE-MATCHED RETROSPECTIVE COHORT STUDY. JOURNAL OF NEUROINTERVENTIONAL SURGERY 0. DOI: 10.1136/JNIS-2025-023229 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 PIPELINE SHIELD REDUCES DIFFUSION-WEIGHTED IMAGING DETECTED ISCHEMIA AFTER INTRACRANIAL ANEURYSM TREATMENT COMPARED WITH PIPELINE FLEX: A PROPENSITY SCORE-MATCHED RETROSPECTIVE COHORT STUDY. THE FOLLOWING MEDTRONIC DEVICES WERE USED: PIPELINE FLEX EMBOLIZATION DEVICE WITH SHIELD TECHNOLOGY (PED SHIELD), PIPELINE FLEX EMBOLIZATION DEVICE, MARKSMAN MICROCATHETER, PHENOM 27 MICROCATHETER. AMONG ALL PATIENTS ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: TECHNICAL EVENTS INCLUDED FISH MOUTHING, TWISTING, AND DEVICE REPLACEMENT DUE TO DEPLOYMENT FAILURE. OF PATIENTS IN THE PED SHIELD G ROUP, 1% (ONE PATIENT) EXPERIENCED TECHNICAL EVENTS. OF PATIENTS IN THE PED FLEX GROUP, 12% (8 PATIENTS) EXPERIENCED TECHNICAL EVENTS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2355240 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK FLEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown