BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 12156609 · Received July 13, 2021

    Report

    Report Number
    2029214-2021-00851
    Event Type
    Injury
    Date Received
    July 13, 2021
    Date of Event
    February 17, 2021
    Report Date
    July 13, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    KAMIDE T, MISAKI K, UNO T, YOSHIKAWA A, UCHIYAMA N, NAKADA M. EXTRACRANIAL-INTRACRANIAL HIGH-FLOW BYPASS AS A RESCUE THERAPY FOR INC OMPLETE CEREBRAL ANEURYSM OCCLUSION AFTER FLOW DIVERSION: A CASE REPORT. SURGICAL NEUROLOGY INTERNATIONAL. 2021;12:57. DOI:10.25259/SNI_836_2020 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH A PIPELINE PROCEDURE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE PIPELINE DEVICE. THE PURPOSE OF THIS ARTICLE WAS TO PROVIDE A CASE REPORT FOR AN EXTRACRANIAL-INTRACRANIAL (EC-IC) HIGH-FLOW BYPASS PROCEDURE AS A RESCUE THERAPY. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: THE PATIENT WAS INITIALLY TREATED WITH ENDOVASCULAR COIL EMBOLIZATION. HOWEVER, CEREBRAL ANGIOGRAPHY PERFORMED 2 YEARS AFTER ENDOVASCULAR COILING SHOWED COIL COMPACTION AND PERSISTENT FILLING INTO THE ANEURYSM, AND THE PATIENT UNDERWENT PLACEMENT OF A PIPELINE DEVICE. THE DISTAL END OF THE STENT WAS POSITIONED JUST PROXIMAL TO THE POSTERIOR COMMUNICATING ARTERY (PCOA). CEREBRAL ANGIOGRAPHY PERFORMED 1 YEAR AFTER INSERTION OF THE PIPELINE DEMONSTRATED REDUCED FILLING INTO THE ANEURYSM, BUT NOT COMPLETE OCCLUSION. IMAGING PERFORMED 2 YEARS AFTER INSERTION OF THE PIPELINE REVEALED INCREASED FILLING INTO THE ANEURYSM, AND IT WAS BELIEVED THAT IT WOULD BE DIFFICULT TO CEASE ANTIPLATELET THERAPY UNDER THESE CONDITIONS. HOWEVER, THE PATIENT WAS REQUIRED TO STOP ANTIPLATELET THERAPY TO RECEIVE SURGICAL TREATMENT FOR SEVERE OSTEOARTHRITIS OF THE KNEE. TO CEASE ANTIPLATELET THERAPY PROMPTLY, IT WAS DECIDED TO PERFORM ICA TRAPPING WITH EC-IC HIGH-FLOW BYPASS AS A RESCUE THERAPY. ANGIOGRAPHY FOLLOWING THIS PROCEDURE REVEALED THAT PCOA FLOW THROUGH EC-IC HIGH-FLOW BYPASS WAS PRESERVED AND COMPLETE OCCLUSION OF THE ANEURYSM WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058383 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention