BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 14164716 · Received April 20, 2022

    Report

    Report Number
    2029214-2022-00680
    Event Type
    Malfunction
    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
    Product Problem
    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. 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. 5 PATIENTS DID NOT HAVE SUCCESSFUL FDS DEPLOYMENT TO AN IDEAL LOCATION BY COVERING THE ANEURYSM NECK. 2 OF THE PATIENTS WITH GIANT ANEURYSMS WERE SUCCESSFULLY MANAGED BY TWO FDS USING THE TELESCOPED TECHNIQUE. 3 PATIENTS WITH GIANT OR LARGE ICA ANEURYSMS, NAVIGATING THE MICROCATHETER TO THE DISTAL ICA PARENT ARTERY TO ALLOW FDS DEPLOYMENT FAILED BECAUSE OF THE DIFFICULT ANATOMY OF THE ANEURYSM TO THE PARENT ARTERY. 3 PATIENTS HAD POOR FDS APPOSITION, AND THE OTHER 2 PATIENTS HAD INSUFFICIENT DAPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005395 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