BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 24554471 · Received March 10, 2026

    Report

    Report Number
    2029214-2026-00396
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    October 18, 2025
    Report Date
    March 9, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: NV UNK PIPELINE, (LOT: UNKNOWN); IMPLANT DATE: N/A; EXPLANT DATE: N/A. CITATION: YAO, J., WANG, Z., WANG, J., JIA, X., LIU, Z., LUO, B., WANG, C., TURHON, M., & ZHANG, Y. PIPELINE EMBOLIZATION DEVICE VERSUS NEUROFORM ATLAS STENT IN THE TREATMENT OF DISTAL ANTERIOR CIRCULATION ANEURYSMS: A RETROSPECTIVE COHORT STUDY. QUANTITATIVE IMAGING IN MEDICINE AND SURGERY 15(11):11032-11043 2025. DOI:10.21037/QIMS-2024-2946 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 EMBOLIZATION DEVICE VERSUS NEUROFORM ATLAS STENT IN THE TREATMENT OF DISTAL ANTERIOR CIRCULATION ANEURYSMS: A RETROSPECTIVE COHORT STUDY.¿ THE TIME FRAME OF THIS STUDY WAS JANUARY 2018 TO DECEMBER 2022. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: 51 PATIENTS INCLUDED IN THE STUDY WERE TREATED WITH A PIPELINE EMBOLIZATION DEVICE (PED). NO DEATHS WERE REPORTED IN THE STUDY POPULATION. AMONG PATIENT ADVERSE EVENTS IN THE PED GROUP INCLUDED: ¿ PERIOPERATIVE ISCHEMIC EVENTS: 2 PATIENTS ¿ PERIOPERATIVE HEMORRHAGIC EVENTS: 4 PATIENTS ¿ FOLLOW-UP ISCHEMIC COMPLICATIONS: 3 PATIENTS ¿ FOLLOW-UP HEMORRHAGIC COMPLICATIONS: 1 PATIENT ¿ IN-STENT STENOSIS: 7 PATIENTS ¿ BRANCH ARTERY OCCLUSION: 3 PATIENTS ¿ UNFAVORABLE NEUROLOGICAL OUTCOMES (MRS 3-6): 2 PATIENTS ¿ STENT ADJUSTMENT WAS PERFORMED IN 4 CASES, ASSISTED BY BALLOON OR STENT RE-SHEATHING NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616611 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Disability