BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 21651527 · Received March 20, 2025

    Report

    Report Number
    2029214-2025-00721
    Event Type
    Death
    Date Received
    March 20, 2025
    Date of Event
    October 15, 2024
    Report Date
    March 20, 2025
    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); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID NV UNK PIPELINE (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: ZHAO, Y., LU, J., LI, Z., CHEN, X., YANG, X., ZHAO, Y., WANG, S., HAO Q.. ANALYZING THE SAFETY AND EFCACY OF PIPELINE EMBOLIZATION DEVICE IN PEDIATRIC ANEURYSMS: INSIGHT FROM A MUL-TICENTER COHORT AND POOLED ANALYSIS. ACTA NEUROCHIRURGICA 166:412 2024. DOI: 10.1007/S00701-024-06306-5. 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

    ANALYZING THE SAFETY AND EFFICACY OF PIPELINE EMBOLIZATION DEVICE IN PEDIATRIC ANEURYSMS: INSIGHT FROM A MULTICENTER COHORT AND POOLED ANALYSIS. THE TIME FRAME OF THIS STUDY WAS: PATIENTS WERE TREATED WITH PED FROM NOVEMBER 2014 TO OCTOBER 2019. LITERATURE REVIEW INCLUDED CASES FROM 2007 TO 2023. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: PIPELINE EMBOLIZATION DEVICE (PED) CLASSIC AND PED FLEX, DEPLOYED THROUGH MARKSMAN AND PHENOM 27 MICROCATHETERS. DEATHS OCCURRED IN THE STUDY POPULATION. THE CAUSES OF DEATH WERE: ACUTE IN-STENT THROMBOSIS LEADING TO ISCHEMIC STROKES (2 CASES). HEMORRHAGIC STROKES FOLLOWING ANEURYSM RUPTURES (2 CASES). (PAGE 4) AMONG PATIENT ADVERSE EVENTS INCLUDED: ISCHEMIC STROKES DUE TO ACUTE IN-STENT THROMBOSIS (2 CASES). HEMORRHAGIC STROKES FOLLOWING ANEURYSM RUPTURES (3 CASES). SYMPTOMATIC PARENT ARTERY STENOSIS (1 CASE). ASYMPTOMATIC PARENT ARTERY STENOSIS (1 CASE). MAJOR MORBIDITY (2 CASES). NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592754 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death SEE H11...