BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 24859731 · Received April 13, 2026

    Report

    Report Number
    2029214-2026-00660
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    August 14, 2025
    Report Date
    May 15, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2. REPORTED PATIENT AGE (53 YEARS) IS THE MEAN AGE FOR ALL PATIENTS INCLUDED IN THE STUDY GROUP. A3. REPORTED PATIENT SEX (FEMALE) IS REPRESENTATIVE OF THE MAJORITY OF PATIENTS INCLUDED IN THE STUDY GROUP. B3. REPORTED EVENT DATE IS DATE THE ARTICLE WAS 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

    HUANG, M., WEN, Z., HU, Y., XU, A., HUANG, J., TONG, X., HUANG, C., MA, G., LIN, J., SHI, H., YUAN, H., GE, R., LI, C., JIA, Z., YI, R., JIN, Y., LIANG, S., LI, X., LIU, A., HANG, X. (2025). THE IMPACT OF CIRCLE OF WILLIS INTEGRITY AND VARIATIONS ON CLINICAL AND RADIOLOGICAL OUTCOMES AFTER POSTERIOR COMMUNICATING ARTERIES COVERED BY FLOW DIVERTER DEVICES. NEUROSURGICAL REVIEW, 48(1). HTTPS://DOI.ORG/10.1007/S10143-025-03740-6 MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND RETROSPECTIVE STUDY OF 164 PATIENTS TREATED FOR 170 POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSMS BETWEEN MARCH 2016 AND JANUARY 2024. THIS STUDY INVESTIGATED THE RELATIONSHIP BETWEEN CIRCLE OF WILLIS (COW) ANATOMICAL VARIATIONS AND OUTCOMES AFTER FLOW DIVERTER (FD) PCOM COVERAGE. THE MEDTRONIC PIPELINE EMBOLIZATION DEVICE (PED) WAS USED IN 99 CASES. OTHER MANUFACTURERS' FLOW DIVERTER STENTS WERE ALSO USED IN OTHER PROCEDURES AND IT WAS NOT SPECIFIED WHAT DEVICE WAS USED IN EACH CASE WITHIN THE ARTICLE. ALL PATIENT'S RECEIVED DUAL ANTIPLATELET THERAPY (DAPT) FOR AT LEAST 3 DAYS PRIOR TO THE PROCEDURE. POST-OPERATIVE IN-STENT STENOSIS (ISS) WAS OBSERVED IN 18 CASES ACROSS THE ENTIRE STUDY GROUP. MOST PATIENTS (14/18) WITH ISS OBSERVED HAD MODIFIED RANKIN SCALE (MRS) SCORE 0. TWO PATIENTS EACH WERE NOTED TO HAVE MRS 1 AND MRS 2; IT WAS NOT SPECIFIED IF THIS ASSESSMENT REPRESENTED AN INJURY OR CHANGE FROM BASELINE. IT WAS NOTED THAT PATIENTS TREATED WITH PIPELINE HAD LOWER RATES OF ISS. OF THE 25 PATIENTS TREATED FOR FETAL POSTERIOR CEREBRAL ARTERY (FPCA) ANEURYSMS, 9 ANEURYSMS WERE NOTED TO HAVE INCOMPLETE OCCLUSION. NO ASSOCIATED PATIENT SYMPTOMS OR ADDITIONAL TREATMENT WAS REPORTED ASSOCIATED WITH THESE FINDINGS AND OCCLUSION RATES FOR OTHER PATIENTS WAS NOT CLEARLY DOCUMENTED. HOWEVER, IT WAS NOTED THAT A COMPLETE COW WAS ASSOCIATED WITH HIGHER ANEURYSM OCCLUSION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563087 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