BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 11309213 · Received February 10, 2021

    Report

    Report Number
    2029214-2021-00165
    Event Type
    Death
    Date Received
    February 10, 2021
    Date of Event
    June 2, 2020
    Report Date
    February 10, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    YANGCHUN LI, STEPHANIE H CHEN, ALEJANDRO M SPIOTTA, PASCAL JABBOUR, MICHAEL R LEVITT, PETER KAN, CHRISTOPH J GRIESSENAUER, ADAM S ARTHUR, JOSHUA W OSBUN, MIN S PARK, NOHRA CHALOUHI, AHMAD SWEID, STACEY Q WOLFE, KYLE M FARGEN, AARON S DUMONT, TRAVIS M DUMONT,16 MARIE-CHRISTINE BRUNET, SAMIR SUR, EVAN LUTHER, ALLISON STRICKLAND, DILEEP R YAVAGAL, ERIC C PETERSON, CLEMENS M SCHIRMER, ODED GOREN, SHAMSHER DALAL, GREGORY WEINER, AXEL ROSENGART, DANIEL RAPER, CHING-JEN CHEN, PETER AMENTA, TYLER SCULLEN, CORY MICHAEL KELLY, CHRISTOPHER YOUNG, MICHAEL NAHHAS, EYAD ALMALLOUHI, ARUNPRASAD GUNASEKARAN, SUHAS PAI, GIUSEPPE LANZINO, WALEED BRINJIKJI, MEHDI ABBASI, DAVID DORNBOS III, NITIN GOYAL, JEREMY PETERSON, MOHAMMAD H EL-GHANEM, ROBERT M STARKE. LOWER COMPLICATION RATES ASSOCIATED WITH TRANSRADIAL VERSUS TRANSFEMORAL FLOW DIVERTING STENT PLACEMENT. JOURNAL OF NEUROINTERVENTIONAL SURGERY 31 (2021). DOI:10.1136/NEURINTSURG-2020-015992. ABSTRACT BACKGROUND CURRENTLY, THERE ARE NO LARGE-SCALE STUDIES IN THE NEUROINTERVENTIONAL LITERATURE COMPARING SAFETY BETWEEN TRANSRADIAL (T RA) AND TRANSFEMORAL (TFA) APPROACHES FOR FLOW DIVERSION PROCEDURES. THIS STUDY AIMS TO ASSESS COMPLICATION RATES IN A LARGE MULTICENTER REGISTRY FOR TRA VERSUS TFA FLOW DIVERSION. METHODS WE RETROSPECTIVELY ANALYZED FLOW DIVERSION CASES FOR CEREBRAL ANEURYSMS FRO M 14 INSTITUTIONS FROM 2010 TO 2019. POOLED ANALYSIS OF PROPORTIONS WAS CALCULATED USING WEIGHTED ANALYSIS WITH 95%CI TO ACCOUNT FOR RESULTS FROM MULTIPLE CENTERS. ACCESS SITE COMPLICATION RATE AND OVERALL COMPLICATION RATE WERE COMPARED BETWEEN THE TWO APPROACHES. RESULTS A TOTAL OF 2,285 PATIENTS WHO UNDERWENT FLOW DIVERSION WERE ANALYZED, WITH 134 (5.86%) TREATED WITH TRA AND 2151 (94.14%) VIA TFA. THE TWO GROUPS SHARED SIMILAR PATIENT AND ANEURYSM CHARACTERISTICS. CROSSOVER FROM TRA TO TFA WAS DOCUMENTED IN 12 (8.63%) PATIENTS. THERE WERE NO ACCESS SITE COMPLICATIONS IN THE TRA GROUP. THERE WAS A SIGNIFICANTLY HIGHER ACCESS SITE COMPLICATION RATE IN THE TFA COHORT AS COMPARED WITH TRA (2.48%, 95%CI 2.40% TO 2.57%, VS 0%;P=0.039). ONE DEATH RESULTED FROM A FEMORAL ACCESS SITE COMPLICATION. THE OVERALL COMPLICATIONS RATE WAS ALSO HIGHER IN THE TFA GROUP (9.02%, 95%CI 8.15% TO 9.89%) COMPARED WITH THE TRA GROUP (3.73%, 95%CI 3.13% TO 4.28%; P=0.035). CONCLUSION TRA MAY BE A SAFER APPROACH FOR FLOW DIVERSION TO TREAT CEREBRAL ANEURYSMS AT A WIDE RANGE OF LOCATIONS. BOTH ACCESS SITE COMPLICATION RATE AND OVERALL COMPLICATION RATE WERE LOWER FOR TRA FLOW DIVERSION COMPARED WITH TFA IN THIS LARGE SERIES. REPORTED EVENTS. - THERE WAS ONE DEATH RESULTING FROM A FEMORAL ACCESS SITE COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203879 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE NOT-REP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death