BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 13485948 · Received February 8, 2022

    Report

    Report Number
    2029214-2022-00177
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    September 14, 2021
    Report Date
    February 8, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED TO RR #: 2029214-2022-00175 WHICH WAS REPORTED FOR DEVICE MALFUNCTION NOTED IN THE SAME ARTICLE. RELATED TO RR# 2029214-2022-00176 WHICH WAS REPORTED FOR PATIENT DEATHS NOTED IN THE SAME ARTICLE. REPORTED PATIENT AGE REFERS TO THE MEDIAN AGE OF ALL PATIENTS INCLUDED IN THE STUDY. REPORTED PATIENT SEX (MALE) REFERS TO THE MAJORITY OF ALL PATIENTS INCLUDED IN THE STUDY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CHEN, J., TAO, M., HAN, J., FENG, X., PENG, F., TONG, X., NIU, H., MA, N., <(>&<)> LIU, A. (2021). PIPELINE EMBOLIZATION DEVICE FOR THE TREATMENT OF UNRUPTURED INTRACRANIAL DISSECTING ANEURYSMS. FRONTIERS IN NEUROLOGY, 12, 691897. HTTPS://DOI.ORG/10.3389/FNEUR.2021.691897. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A STUDY IN WHICH 80 PATIENTS HAD PIPELINE EMBOLIZATION DEVICES (PEDS) IMPLANTED FOR THE TREATMENT OF INTRACRANIAL DISSECTING ANEURYSMS (IDAS). PED ONLY WAS USED TO TREAT 61 ANEURYSMS AND PED WITH ADJUNCTIVE COIL WAS USED TO TREAT 12 ANEURYSMS. SUCCESSFUL PED DEPLOYMENT WAS ACHIEVED FOR ALL PATIENTS THOUGH 2 REQUIRED A SECOND ATTEMPT FOR SUCCESSFUL DEPLOYMENT. FAVORABLE OUTCOME WAS NOTED TO BE 95%. THE CONCLUSION OF THE ARTICLE WAS THAT RECONSTRUCTION USING A PED IS SAFE AND EFFECTIVE IN THE TREATMENT OF UNRUPTURED IDAS, SHOWING FAVORABLE LONG-TERM CLINICAL AND ANGIOGRAPHIC OUTCOMES. HOWEVER, THE COMPLICATIONS OF THIS TREATMENT SHOULD BE NOTED. CAREFUL SELECTION OF APPROPRIATE PATIENTS AND INDIVIDUALIZED ANTIPLATELET THERAPY MIGHT BE NEEDED. 1 PATIENT HAD PERFORATOR ARTERY OCCLUSION DURING THE PROCEDURE. TIROFIBAN WAS ADMINISTERED AFTER HEMORRHAGE WAS RULED OUT. THIS PATIENT DID NOT DEVELOP ANY NEW SYMPTOMS AFTER TREATMENT AND RECOVERED WELL. 1 PATIENT HAD IN-STENT THROMBOSIS INTRA-OPERATIVELY AND TIROFIBAN WAS ADMINISTERED PROXIMAL TO THE THROMBUS INTRA-ARTERIALLY THROUGH A MICROCATHETER. THE PATIENT RECOVERED WELL AT FOLLOW-UP. 1 PATIENT, WHO HAD BEEN TREATED FOR BASILAR ARTERY IDA, HAD CEREBRAL INFARCTION DIAGNOSED AT A LOCAL HOSPITAL 5 MONTHS POST-OPERATIVE AND WAS SEVERELY DISABLED WITH MODIFIED RANKIN SCALE (MRS) OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850321 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention| S