BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 13596666 · Received February 24, 2022

    Report

    Report Number
    2029214-2022-00301
    Event Type
    Death
    Date Received
    February 24, 2022
    Date of Event
    April 29, 2021
    Report Date
    February 24, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    KANG, H., LUO, B., LIU, J., ZHANG, H., LI, T., SONG, D., ZHAO, Y., GUAN, S., MAIMAITILI, A., WANG, Y., FENG, W., WANG, Y., WAN, J., MAO, G., SHI, H., ZHANG, Y., & AMP; YANG, X. (2021). POSTOPERATIVE OCCLUSION DEGREE AFTER FLOW-DIVERTER PLACEMENT WITH ADJUNCTIVE COILING: ANALYSIS OF COMPLICATIONS. JOURNAL OF NEUROINTERVENTIONAL SURGERY. HTTPS://DOI.ORG/10.1136/NEURINTSURG-2021-017445. AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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

    KANG, H., LUO, B., LIU, J., ZHANG, H., LI, T., SONG, D., ZHAO, Y., GUAN, S., MAIMAITILI, A., WANG, Y., FENG, W., WANG, Y., WAN, J., MAO, G., SHI, H., ZHANG, Y., & AMP; YANG, X. (2021). POSTOPERATIVE OCCLUSION DEGREE AFTER FLOW-DIVERTER PLACEMENT WITH ADJUNCTIVE COILING: ANALYSIS OF COMPLICATIONS. JOURNAL OF NEUROINTERVENTIONAL SURGERY. HTTPS://DOI.ORG/10.1136/NEURINTSURG-2021-017445. SUMMARY: ALTHOUGH COILING WITH A FLOW DIVERTER MAY PROVIDE IMMEDIATE DOME PROTECTION, NO STUDIES HAVE EVALUATED THE EFFECT ON COMPLICATIONS OF POSTOPERATIVE OCCLUSION DEGREE IMMEDIATELY POSTOPERATIVELY. THE PURPOSE OF THIS STUDY WAS TO DETERMINE WHETHER POSTOPERATIVE OCCLUSION DEGREE IMMEDIATELY AFTER FLOW-DIVERTER PLACEMENT WITH ADJUNCTIVE COILING WAS ASSOCIATED WITH COMPLICATIONS IDENTIFIED EVENTS: 1. THERE WAS MORTALITY OF 17 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230333 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Death