BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 11842041 · Received May 18, 2021

    Report

    Report Number
    2029214-2021-00591
    Event Type
    Death
    Date Received
    May 18, 2021
    Date of Event
    December 1, 2020
    Report Date
    May 18, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. ENOMOTO, Y., EGASHIRA, Y., MATSUBARA, H., YOSHIMURA, S., IWAMA, T., LONG-TERM OUTCOME OF ENDOVASCULAR THERAPY FOR LARGE OR GIANT THROMBOSED INTRACRANIAL ANEURYSMS, WORLD NEUROSURGERY, VOLUME 144, 2020, PAGES E507-E512, ISSN 1878-8750,HTTPS://DOI.ORG/10.1016/J.WNEU.2020.08.213. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENOMOTO, Y., EGASHIRA, Y., MATSUBARA, H., YOSHIMURA, S., IWAMA, T., LONG-TERM OUTCOME OF ENDOVASCULAR THERAPY FOR LARGE OR GIANT THROMBOSED INTRACRANIAL ANEURYSMS, WORLD NEUROSURGERY, VOLUME 144, 2020, PAGES E507-E512, ISSN 1878-8750,HTTPS://DOI.ORG/10.1016/J.WNEU.2020.08.213 MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH PIPELINE FLEX IMPLANTATION FOR TREATMENT OF LARGE OR GIANT THROMBOSED INTRACRANIAL ANEURYSMS. THE PURPOSE OF THIS ARTICLE WAS TO UNDERSTAND LONG-TERM CLINICAL AND ANGIOGRAPHIC OUTCOMES OF EVT FOR LGTIAS, WE RETROSPECTIVELY ANALYZED OUR SINGLE-CENTER DATA ON MULTIMODALITY ENDOVASCULAR TREATMENT (EVT) FOR PATIENTS WITH LARGE OR GIANT THROMBOSED INTRACRANIAL ANEURYSMS (LGTIAS). THE AUTHORS REVIEWED 31 CASES OF PATIENTS TREATED FOR LGTIAS USING EITHER A DECONSTRUCTIVE TREATMENT WHICH INCLUDED PARENT ARTERY OCCLUSION, TRAPPING, OR PROXIMAL OCCLUSION WITH COILS, OR A RECONSTRUCTIVE TREATMENT WHICH INCLUDED COILING WITH OR WITHOUT VESSEL RECONSTRUCTIVE DEVICES, SUCH AS A STENT OR FLOW DIVERTER. OF THE 31 PATIENTS, 21 UNDERWENT A RECONSTRUCTIVE TREATMENT WITH USE OF A PIPELINE FLEX STENT OR A NON-MEDTRONIC STENT. THE ARTICLE DOES NOT DIFFERENTIATE WHICH PATIENTS WERE TREATED WITH THE PIPELINE FLEX AS OPPOSED TO A NON-MEDTRONIC STENT. OF THE 31 PATIENTS, THE AVERAGE AGE WAS 65.8 YEARS, 21 WERE FEMALE AND 10 WERE MALE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE PIPELINE FLEX. A FAVORABLE OUTCOME AT 12 MONTHS AFTER THE INITIAL EVT WAS OBTAINED FOR 23 PATIENTS (74.2%). THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: 1. MORTALITY BY 12 MONTHS AFTER THE INITIAL EVT AFFECTED 2 PATIENTS DUE TO PROCEDURE-RELATED COMPLICATIONS: 1 VESSEL PERFORATION FOLLOWED BY FATAL SUBARACHNOID HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737146 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death