BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 10949844 · Received December 4, 2020

    Report

    Report Number
    2029214-2020-01233
    Event Type
    Death
    Date Received
    December 4, 2020
    Date of Event
    July 6, 2020
    Report Date
    December 4, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AGE PROVIDED IN THIS REPORT REPRESENTS THE MEDIAN AGE OF ALL PATIENT INCLUDED IN THIS STUDY LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    GRIESSENAUER, C.J., ENRIQUEZ-MARULANDA, A., TAUSSKY, P., BISWAS, A., GRANDHI, R., XIANG, S., HONG, T., RINALDO, L., LANZINO, G., BRINJIKJI, W., BURKHARDT, J., KAN, P., GHUMAN, M., YANG, V.X.D., CHEN, K., AZIZ-SULTAN, M.A., GHORBANI, M., SCHIRMER, C.M., GOREN, O., DALAL, S.S., KILLER-OBERPFALZER, M., MULLER-THIES-BROUSSALIS, E., KOCH, M.J., STAPLETON, C.J., PATEL, A.B., FOREMAN, P.M., CRESS, M.C., HIRSCHL, R.A., KRINGS, T., ZHANG, H., DMYTRIW, A.A. (2020). EXPERIENCE WITH THE PIPELINE EMBOLIZATION DEVICE FOR POSTERIOR CIRCULATIONS ANEURYSMS: A MULTICENTER COHORT STUDY. NEUROSURGERY, 87(6), 1252-1261. ABSTRACT BACKGROUND: THE PIPELINE EMBOLIZATION DEVICE (PED; MEDTRONIC) HAS BEEN USED OFF LABEL FOR THE TREATMENT OF CHALLENGING POSTERIOR CIRCULATION ANEURYSMS. DATA ON THIS MODALITY ARE PRIMARILY LIMITED TO SMALL RETROSPECTIVE SINGLE-CENTER SERIES. OBJECTIVE: TO ASSESS SAFETY AND EFFICACY OF THIS TREATMENT BY ESTABLISHING AN INTERNATIONAL, MULTICENTER COLLABORATION. METHODS: CONSECUTIVE POSTERIOR CIRCULATION ANEURYSMS TREATED WITH THE PED FROM 2012 TO 2019 ACROSS 11 NEUROVASCULAR CENTERS WERE RET ROSPECTIVELY REVIEWED. BASELINE DEMOGRAPHICS, ANEURYSM AND TREATMENT CHARACTERISTICS, COMPLICATIONS, OCCLUSION STATUS, AND FUNCTIONAL OUTCOME WERE ASSESSED. RESULTS: THERE WERE 149 POSTERIOR CIRCULATION ANEURYSMS TREATED WITH PED IN 146 PATIENTS. A TOTAL OF 24 (16.4%) PATIENTS PRESENTED WITH SUBARACHNOID HEMORRHAGE. MOST ANEURYSMS WERE DISSECTING/BLISTER (36.2%) IN MORPHOLOGY, FOLLOWED BY SACCULAR (35.6%) AND FUSIFORM (28.2%). THE MOST COMMON LOCATIONS WERE THE VERTEBRAL (51.7%) AND BASILAR ARTERIES (22.8%). COMPLETE OR NEAR-COMPLETE OCCLUSION (>90%) WAS ACHIEVED IN 90.9% OF ANEURYSMS AT A MEDIAN FOLLOW-UP OF 12 MO. DISSECTING/BLISTER ANEURYSMS WERE MOST LIKELY TO OCCLUDE (P = .06). SYMPTOMATIC NEUROLOGIC COMPLICATIONS OCCURRED IN 9.4% OF ANEURYSMS, ASSOCIATED WITH LARGER SIZE, RUPTURED PRESENTATION, PRESENTATIONS WITH BRAIN STEM COMPRESSION, CRANIAL NERVE PALSY, OR STROKE. FAVORABLE FUNCTIONAL OUTCOME (MODIFIED RANKIN SCORE 0-2) WAS ACHIEVED IN 86.2% OF PATIENTS. THERE WERE 6 FATALITIES OF WHICH 4 OCCURRED IN ANEURYSMAL SUBARACHNOID HEMORRHAGE PATIENTS. CONCLUSION: THIS MULTICENTER STUDY SHOWS THAT PED FOR THE TREATMENT OF POSTERIOR CIRCULATION IS PREFERENTIALLY USED FOR THE TREATMENT OF FUSIFORM AND DISSECTING/BLISTER ANEURYSM MORPHOLOGIES. DESPITE THE CHALLENGES PRESENTED BY THESE LESS-COMMON MORPHOLOGIES, FLOW DIVERSION MAY BE PERFORMED WITH A NEUROLOGIC COMPLICATION RATE OF ABOUT 10% AND FAVORABLE LONG-TERM ANEURYSM OCCLUSION RATES. PLI10: 6 PATIENTS INCLUDED IN THE STUDY DIED. 1 PATIENT REPORTEDLY DIED DUE TO UNRELATED LIVER CIRRHOSIS. 4 PATIENTS IN THE STUDY WHO DIED HAD SUBARACHNOID HEMORRHAGE PRIOR TO THE PIPELINE PROCEDURE. THEREFORE, 5 PATIENTS DIED OF CAUSES THAT COULD HAVE POSSIBLY BEEN RELATED TO THE PROCEDURE OR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411917 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE NOT-RPT

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death