BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 20452166 · Received October 15, 2024

    Report

    Report Number
    2029214-2024-01882
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    November 15, 2023
    Report Date
    October 15, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: SREENIVASAN, S., ROYCHOWDHURY, S., KASHIBATHLA, A., KUMARAPURAM, S., NOUROLLAH-ZADEH, E., SUNDARARAJAN, S., SUN, H., NANDA, A., GUPTA, G.. FLOW DIVERSION FOR TREATMENT OF ANTERIOR INFERIOR CEREBELLAR ARTERY ANEURYSMS: MECHANISM AND PITFALLS FROM A NOVEL MANAGEMENT STRATEGY. WORLD NEUROSURG 182:E163-E170 2024. DOI: 10.1016/J.WNEU.2023.11.064 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 FLOW DIVERSION FOR TREATMENT OF ANTERIOR INFERIOR CEREBELLAR ARTERY ANEURYSMS: MECHANISM AND PITFALLS FROM A NOVEL MANAGEMENT STRATEGY. THE TIME FRAME OF THIS STUDY WAS 6 MONTHS. MULTIPLE MANUFACTURERS' DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: PIPELINE SHIELD FD, SYNCHRO WIRE, PHENOM PLUS GUIDE CATHETER, AND PHENOM MICROCATHETER DEATHS OCCURRED IN THE STUDY POPULATION: NO DEATHS OR CAUSES OF DEATH RELATED TO MEDTRONIC DEVICES WERE FOUND. AMONG PATIENT ADVERSE EVENTS INCLUDED: CASE 1: A 56-YEAR-OLD MALE PATIENT PRESENTED WITH A SUDDEN-ONSET THUNDERCLAP HEADACHE. COMPUTED TOMOGRAPHY (CT) SHOWED SUBARACHNOID HEMORRHAGE (SAH) WITH PERIMESENCEPHALIC, CISTERNAL, AND INTRAVENTRICULAR HEMORRHAGE. USING ROADMAP GUIDANCE, A 4 15 MM PIPELINE SHIELD FD WAS DEPLOYED USING PUSHER WIRE AND OCCASIONALLY UNSHEATHING TO MAKE SURE THAT THERE WAS GOOD WALL APPOSITION AND EXACT PLACEMENT OF THE STENT EXTENDING FROM THE PROXIMAL TO SUPERIOR CEREBELLAR ARTERY (SCA) ORIGIN AND ENDING JUST ABOVE THE VERTEBROBASILAR FENESTRATION. THIS PATIENT HAD PERSISTENT VASOSPASM IN THE PERIOD AFTER FD EMBOLIZATION. AN INITIAL DECLINE IN CONSCIOUSNESS ON DAY 2 WAS FOLLOWED BY RECOVERY TOWARD BASELINE CLINICAL EXAMINATION STATUS ON DAY 7. FOLLOW-UP ANGIOGRAPHY AT 6 MONTHS SHOWED COMPLETE RESOLUTION OF THE ANEURYSM. THE PATIENT DID NOT HAVE ANY NEUROLOGIC SEQUELAE AT THE 6 MONTHS FOLLOW-UP VISIT. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37003 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