BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 21660095 · Received March 20, 2025

    Report

    Report Number
    2029214-2025-00730
    Event Type
    Injury
    Date Received
    March 20, 2025
    Date of Event
    August 26, 2024
    Report Date
    March 20, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    SUJIJANTARAT, N., ANTONIOS, J. P., RENEDO, D., KOO, A. B., HAYNES, J. O., FATHIMA, B., JIANG, J. W., HENGARTNER, A. C., SHEKHAR, A. H., AMLLAY, A., NOWICKI, K. W., HEBERT, R. M., GILMORE, E. J., SHETH; CLINICAL NEUROLOGY AND NEUROSURGERY; 2024; 246; IMPROVEMENT IN CRANIAL NERVE PALSIES FOLLOWING TREATMENT OF INTRACRANIAL ANEURYSMS WITH FLOW DIVERTERS: INSTITUTIONAL OUTCOMES, SYSTEMATIC REVIEW AND STUDY-LEVEL META-ANALYSIS; DOI.ORG/10.1016/J.CLINEURO.2024.108555. LITERATURE WAS REVIEWED REGARDING: "IMPROVEMENT IN CRANIAL NERVE PALSIES FOLLOWING TREATMENT OF INTRACRANIAL ANEURYSMS WITH FLOW DIVERTERS: INSTITUTIONAL OUTCOMES, SYSTEMATIC REVIEW AND STUDY-LEVEL META-ANALYSIS." THE OBJECTIVE WAS TO REPORT INSTITUTIONAL OUTCOMES AND SUMMARIZE RATES OF IMPROVEMENT IN CRANIAL NERVE (CN) PALSIES FOLLOWING FLOW DIVERSION TREATMENT FOR INTRACRANIAL ANEURYSMS, AS WELL AS TO IDENTIFY FACTORS ASSOCIATED WITH RECOVERY FROM CN SYMPTOMS. THE TIME FRAME OF THIS STUDY WAS: JANUARY 2015 TO DECEMBER 2023. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE DEVICES INCLUDED THE PIPELINE EMBOLIZATION DEVICE FROM MEDTRONIC, AS WELL AS DEVICES FROM OTHER MANUFACTURERS. THERE WAS NO INFORMATION PROVIDED REGARDING DEATHS, THEIR CAUSES, OR NUMBERS. AMONG PATIENT ADVERSE EVENTS INCLUDED: ONE INTRAPROCEDURAL COMPLICATION (8%) DUE TO CATHETER-RELATED VASOSPASM, WHICH RESOLVED WITH INTRA-ARTERIAL VERAPAMIL INJECTION. ONE POST-OPERATIVE COMPLICATION FROM ANGIO-SEAL FAILURE CAUSING HEMATOMA AFTER AMBULATION, REQUIRING DIRECT ARTERIAL REPAIR IN THE OPERATING ROOM. THE OVERALL RATE OF CLINICAL IMPROVEMENT WAS 67 % AT THE LAST CLINICAL FOLLOW-UP VISIT. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335989 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention