BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE

    MDR report key: 23223141 · Received October 6, 2025

    Report

    Report Number
    2029214-2025-02141
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    May 13, 2022
    Report Date
    October 6, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID NV UNK PIPELINE (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A CITATION: LEE, J. D. E., RICHARDS, E., MAWJI, S., PALUZZI, A., TSERMOULAS, G., <(>&<)> AHMED, S.. THE ¿MUSCLE WONTON¿ REPAIR ¿ A CASE SERIES OF INTERNAL CAROTID ARTERY INJURIES AT A SINGLE CENTRE DURING ITS 10-YEAR EXPERIENCE IN ENDOSCOPIC TRANSSPHENOIDAL PITUITARY SURGERY. BRITISH JOURNAL OF NEUROSURGERY 38(4), 934¿938 2024. HTTPS://DOI.ORG/10.1080/02688697.2021.20 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 'THE ¿MUSCLE WONTON¿ REPAIR ¿ A CASE SERIES OF INTERNAL CAROTID ARTERY INJURIES AT A SINGLE CENTRE DURING ITS 10-YEAR EXPERIENCE IN ENDOSCOPIC TRANSSPHENOIDAL PITUITARY SURGERY'. THE TIME FRAME OF THIS STUDY WAS JANUARY 2010 TO DECEMBER 2019. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: PIPELINE FLOW DIVERTERS WERE USED TO TREAT AN INTERNAL CAROTID ARTERY (ICA) INJURY. AMONG PATIENT ADVERSE EVENTS INCLUDED: THREE PIPELINE STENTS WERE DELIVERED, AND A POST-PROCEDURE CT HEAD REVEALED NO EVIDENCE OF ISCHAEMIA, BLEEDING OR HYDROCEPHALUS, DESPITE SHOWING THE DEFECT THROUGH WHICH THE ICA TEAR OCCURRED. TWO DAYS POST-INJURY, A REPEAT ANGIOGRAM SHOWED A PERSISTENT LEAK OF THE RIGHT ICA, AND IT WAS DECIDED TO PLACE A FOURTH PIPELINE STENT WITHIN THE CONSTRUCT, WHICH INITIALLY SEALED THE IATROGENIC TEAR. UNFORTUNATELY, THE PROXIMAL END OF THE STENT FAILED TO OPEN DESPITE ATTEMPTS MADE TO RECTIFY THIS USING TWO TYPES OF REMODELLING BALLOONS. A PARENT VESSEL OCCLUSION WAS EVENTUALLY PERFORMED IN VIEW OF A RAPIDLY ACCUMULATING CLOT ON THE FOURTH PIPELINE STENT AND THE PATIENT WAS STABLE FOLLOWING THIS. THE PATIENT REMAINED ASYMPTOMATIC AND DID NOT SHOW ANY DETERIORATION IN IMAGING OR CLINICAL SYMPTOMS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478019 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male SEE H11...