BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 13615093 · Received February 27, 2022

    Report

    Report Number
    2029214-2022-00318
    Event Type
    Injury
    Date Received
    February 27, 2022
    Date of Event
    January 1, 2021
    Report Date
    February 27, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LAUZIER, D. C., ROOT, B. K., KAYAN, Y., ALMANDOZ, J. E., OSBUN, J. W., CHATTERJEE, A. R., WHALEY, K. L., TIPPS, M. E., MORAN, C. J., KANSAGRA, A. P. (2021). PIPELINE EMBOLIZATION OF DISTAL POSTERIOR INFERIOR CEREBELLAR ARTERY ANEURYSMS. INTERVENTIONAL NEURORADIOLOGY, 27(6), 821¿827. HTTPS://DOI.ORG/10.1177/15910199211013195. SUMMARY: FLOW DIVERSION IS COMMONLY USED TO TREAT INTRACRANIAL ANEURYSMS IN VARIOUS REGIONS OF THE CEREBRAL VASCULATURE, BUT IS ONLY APPROVED FOR USE IN THE INTERNAL CAROTID ARTERIES. TREATMENT OF DISTAL PICA ANEURYSMS WITH PED IS SOMETIMES PERFORMED BUT HAS NOT BEEN WELL STUDIED. HERE, WE REPORT OUR EXPERIENCE WITH FLOW DIVERSION OF DISTAL PICA ANEURYSMS WITH PED. IDENTIFIED EVENTS: PLI ONE PATIENT UNDERWENT FLOW DIVERSION WITHOUT ANY IMMEDIATE PERIOPERATIVE CLINICAL OR TECHNICAL COMPLICATIONS. THE PATIENT WAS DIS CHARGED TO HOME AFTER TREATMENT AT NEUROLOGICAL BASELINE. FIVE MONTHS LATER, THE PATIENT WAS ADMITTED TO ANOTHER HOSPTIAL WITH SEVERE HYPERTENSION AND FOUND TO HAVE A HYPERTENSIVE INTRACRANIAL HEMORRHAGE IN THE BASIL GANGLIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2054469 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 Hospitalization