BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 13434615 · Received February 2, 2022

    Report

    Report Number
    2029214-2022-00142
    Event Type
    Death
    Date Received
    February 2, 2022
    Date of Event
    February 4, 2021
    Report Date
    February 2, 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., WANG, K., YANG, X. (2021). MORTALITY AFTER TREATMENT OF INTRACRANIAL ANEURYSMS WITH THE PIPELINE EMBOLIZATION DEVICE. JOURNAL OF NEUROINTERVENTIONAL SURGERY. HTTPS://DOI.ORG/10.1136/NEURINTSURG-2020-017002. 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 AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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., WANG, K., YANG, X. (2021). MORTALITY AFTER TREATMENT OF INTRACRANIAL ANEURYSMS WITH THE PIPELINE EMBOLIZATION DEVICE. JOURNAL OF NEUROINTERVENTIONAL SURGERY. HTTPS://DOI.ORG/10.1136/NEURINTSURG-2020-017002. SUMMARY: THE PIPELINE EMBOLIZATION DEVICE (PED) IS REPORTED TO BE A SAFE TREATMENT TOOL FOR ANEURYSMS. HOWEVER, MORTALITY OCCURS IN A FEW CASES, AND THIS HAS NOT BEEN CLEARLY STUDIED. WE CONDUCTED A MULTICENTER STUDY TO RETROSPECTIVELY EVALUATE THE CAUSES OF, AND RISK FACTORS FOR, MORTALITY IN PATIENTS WITH INTRACRANIAL ANEURYSMS TREATED WITH THE PED. WE RETROSPECTIVELY REVIEWED THE PROSPECTIVELY MAINTAINED DATABASES OF PATIENTS WITH INTRACRANIAL ANEURYSMS TREATED BY PED PLACEMENT AT 14 ACADEMIC INSTITUTIONS FROM 2014 TO 2019. PATIENTS¿ DATA, INCLUDING CLINICAL AND RADIOGRAPHIC INFORMATION, WERE ANALYZED WITH AN EMPHASIS ON MORTALITY-RELATED COMPLICATIONS. IDENTIFIED EVENTS: 1 PATIENT DIED DUE TO BRAINSTEM COMPRESSION OF ANEURYSM TREATED WITH PIPELINE ADJUNCTIVE COILING. 1 PATIENT DIED DUE TO BRAINSTEM COMPRESSION. 1 PATIENT DIED DUE TO ANEURYSM RUPTURE, HYDROCEPHALUS. 1 PATIENT DIED DUE TO DICH (DEEP INTRACEREBRAL HEMORRHAGE), HYDROCEPHALUS. 2 PATIENT DIED DUE TO ANEURYSM RUPTURE, ICH (INTRACEREBRAL HEMORRHAGE). 4 PATIENTS DIED DUE TO ANEURYSM RUPTURE, SAH (SUBARACHNOID HEMORRHAGE). 2 PATIENTS DIED DUE TO DICH. 1 PATIENT DIED DUE TO ANEURYSM RUPTURE, SAH, ICH. 1 PATIENT DIED DUE TO ISCHEMIC STROKE (PIPELINE THROMBOSIS). 1 PATIENT DIED DUE TO INTRACRANIAL INFECTION, HYDROCEPHALUS. DEVICE INFORMATION: 4 PATIENTS USED PED CLASSIC AND 13 USED PED FLEX. ANEURYSM SHAPE: 12 SACCULAR ANEURYSMS, 3 FUSIFORM ANEURYSMS, 1 BLISTER ANEURYSM, AND 1 LOBULATED WITH DAUGHTER SAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1779341 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Death