BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 14164713 · Received April 20, 2022

    Report

    Report Number
    2029214-2022-00679
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    August 11, 2021
    Report Date
    April 20, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FENG, S.-W., LUO, C.-B., LEE, C.-H., CHANG, F.-C., <(>&<)> LIN, C.-J. (2021). FLOW-DIVERTER STENT TO MANAGE INTRACRANIAL ANEURYSMS: A SINGLE CENTER EXPERIENCE. JOURNAL OF THE CHINESE MEDICAL ASSOCIATION, 85(3), 358¿363. HTTPS://DOI.ORG/10.1097/JCMA.0000000000000619. 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 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

    FENG, S.-W., LUO, C.-B., LEE, C.-H., CHANG, F.-C., <(>&<)> LIN, C.-J. (2021). FLOW-DIVERTER STENT TO MANAGE INTRACRANIAL ANEURYSMS: A SINGLE CENTER EXPERIENCE. JOURNAL OF THE CHINESE MEDICAL ASSOCIATION, 85(3), 358¿363. HTTPS://DOI.ORG/10.1097/JCMA.0000000000000619 SUMMARY: ENDOVASCULAR COIL EMBOLIZATION IS AN IMPORTANT METHOD FOR MANAGING INTRACRANIAL ANEURYSMS. HOWEVER, ANEURYSM COILING MAY FAIL OR BE INSUFFICIENT IN GEOGRAPHICALLY DIFFICULT ANEURYSMS. A FLOW-DIVERTER STENT (FDS) IS AN ALTERNATIVE IN THESE DIFFICULT COILING ANEURYSMS. THUS, THIS STUDY REPORTS THE EXPERIENCE AND OUTCOME OF FDS MANAGEMENT OF INTRACRANIAL ANEURYSMS. IDENTIFIED EVENTS: 1. 3 PATIENTS HAD IN-STENT THROMBOSIS THAT WAS SOLVED BY PERCUTANEOUS BALLOON ANGIOPLASTY TO IMPROVE THE FDS APPOSITION. 2. 2 PATIENTS HAD DISTAL EMBOLIZATION THAT WAS SOLVED BY PERCUTANEOUS BALLOON ANGIOPLASTY TO IMPROVE THE FDS APPOSITION. 3. 1 OF THE PATIENT'S HAD AN IATROGENIC DIRECT CAROTID-CAVERNOUS FISTULA BECAUSE OF THE PERFORATION OF CAVERNOUS ICA BY THE GUIDEWIRE. CONSEQUENTLY, THE PATIENT UNDERWENT TRANVENOUS COILING WITH FISTULA CURE. 4. 1 PATIENT HAD AN ANEURYSM RUPTURE. 5. 1 PATIENT HAD A PERMANENT PROCEDURE-RELATED MORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005392 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK FLEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention