BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 21654750 · Received March 20, 2025

    Report

    Report Number
    2029214-2025-00728
    Event Type
    Injury
    Date Received
    March 20, 2025
    Date of Event
    February 14, 2025
    Report Date
    March 24, 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); IMPLANT DATE: N/A; EXPLANT DATE: N/A. G2: CITATION: AUTHORS: HUANG, M., FENG, X., WEN, Z., HUANG, C., HUANG, J., XU, A., TONG, X., MA, G., LIN, J., SHI, H., HU, Y., YUAN, H., GE, R., LI, C., JIA, C., YI, R., JIN, Y., LIANG, S., LI, X., WANG, X., LIU, A., DUAN. COMPARISON OF TUBRIDGE AND PIPELINE EMBOLISATION DEVICES IN INTRACRANIAL ANEURYSMS: A MULTICENTRE, PROPENSITY-MATCHING ANALYSIS ON THE PATENCY OF BRANCH VESSELS. NEUROSURGICAL REVIEW 48:237 2025. 48:237. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    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: THE STUDY TITLED "COMPARISON OF TUBRIDGE AND PIPELINE EMBOLISATION DEVICES IN INTRACRANIAL ANEURYSMS: A MULTICENTRE, PROPENSITY-MATCHING ANALYSIS ON THE PATENCY OF BRANCH VESSELS." THE OBJECTIVE IS TO COMPARE THE IMPACT OF TWO FLOW DIVERTER DEVICES (PIPELINE EMBOLIZATION DEVICE [PED] AND TUBRIDGE EMBOLIZATION DEVICE [TED]) ON BRANCH VESSELS PATENCY IN INTRACRANIAL ANEURYSM TREATMENT, FOCUSING ON BRANCH VESSEL OUTCOMES AND CLINICAL SAFETY. THE TIME FRAME OF THIS STUDY WAS: THE STUDY COLLECTED DATA ON CONSECUTIVE PATIENTS TREATED WITH PED OR TED BETWEEN MARCH 2019 AND OC TOBER 2023 MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION PIPELINE EMBOLISATION DEVICE (PED) FROM MEDTRONIC AND THE TUBRIDGE EMBOLISATION DEVICE (TED) FROM MICROPORT MEDICAL COMPANY THE FOLLOWING MEDTRONIC DEVICES WERE USED: THE MEDTRONIC DEVICE USED IN THE STUDY IS THE PIPELINE EMBOLISATION DEVICE (PED). NO DEATHS OCCURRED IN THE STUDY POPULATION AMONG PATIENT ADVERSE EVENTS INCLUDED: HEMORRHAGIC EVENTS (SUBARACHNOID HEMORRHAGE AND PARENCHYMAL HEMORRHAGE), ISCHEMIC COMPLICATIONS CLASSIFIED BASED ON NIHSS SCORES, IN-STENT THROMBOSIS, TRANSIENT ISCHEMIC ATTACK, NERVE PALSY, VISUAL DEFICITS, CRANIAL NEUROPATHY, NEUROLOGICAL DEFICITS ASSESSED USING MRS AT DISCHARGE, PERIOPERATIVE COMPLICATIONS WERE OBSERVED IN THE OCCLUDED OA GROUP (8.7% V S. 0.4% IN THE PATENT GROUP, P = 0.021). NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454829 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening