BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 10100829 · Received May 29, 2020

    Report

    Report Number
    2029214-2020-00503
    Event Type
    Death
    Date Received
    May 29, 2020
    Date of Event
    February 26, 2018
    Report Date
    May 29, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    ADAM A. DMYTRIW, NIMER ADEEB, ASHISH KUMAR, CHRISTOPH J. GRIESSENAUER, KEVIN PHAN, CHRISTOPHER S. OGILVY, PAUL M. FOREMAN, HUSSAIN SHALLWANI, NICOLA LIMBUCCI, SALVATORE MANGIAFICO, CATERINA MICHELOZZI, TIMO KRINGS ,MD, VITORMENDES PEREIRA,MD, CHARLES C. MATOUK, YUCHEN ZHANG, MARK R. HARRIGAN, HAKEEM J. SHAKIR, ADNAN H. SIDDIQUI, ELAD I. LEVY, LEONARDO RENIERI, CHRISTOPHE COGNARD, AJITH J. THOMAS, THOMAS R. MAROTTA. FLOW DIVERSION FOR THE TREATMENT OF BASILAR APEX ANEURYSMS. NEUROSURGERY 83 (2018). DOI:10.1093/NEUROS/NYX628. BACKGROUND: FLOW DIVERSION FOR BASILAR APEX ANEURYSMS HAS RARELY BEEN REPORTED. OBJECTIVE: TO ASSESS FLOW DIVERSION FOR BASILAR APEX ANEURYSMS IN A MULTICENTER COHORT. METHODS: RETROSPECTIVE REVIEW OF PROSPECTIVELY MAINTAINED DATABASES AT 8 ACADEMIC INSTITUTIONS WAS PERFORMED FROM 2009 TO 2016 TO IDENTIFY PATIENTS WITH BASILAR APEX ANEURYSMS TREATED WITH FLOW DIVERSION. CLINICAL AND RADIOGRAPHIC DATA WERE ANALYZED. RESULTS: SIXTEEN CONSECUTIVE PATIENTS (MEDIAN AGE 54.5 YR) UNDERWENT 18 PROCEDURES TO TREAT 16 BASILAR APEX ANEURYSMS WITH EITHER THE PIPELINE EMBOLIZATION DEVICE (MEDTRONIC INC, (B)(4)) OR FLOW REDIRECTION ENDOLUMINAL DEVICE (MICROVENTION, (B)(4)). FIVE ANEURYSMS (31.3%) WERE TREATED IN THE SETTING OF SUBARACHNOID HEMORRHAGE. SEVEN ANEURYSMS (43.8%) WERE TREATED WITH FLOW DIVERSION ALONE, WHILE 9 (56.2%) UNDERWENT FLOWDIVERSION AND ADJUNCTIVE COILING. AT A MEDIAN FOLLOW-UP OF 6 MO, COMPLETE (100%) AND NEAR-COMPLETE (90%-99%) OCCLUSION WAS NOTED IN 11 (68.8%) ANEURYSMS. INCOMPLETE OCCLUSION OCCURRED MORE COMMONLY IN PATIENTS TREATED WITH FLOW DIVERSION ALONE COMPARED TO THOSE WITH ADJUNCTIVE COILING. PATIENTS WITH PARTIAL OCCLUSION WERE SIGNIFICANTLY YOUNGER. RETREATMENT WITH AN ADDITIONAL FLOW DIVERTER AND ADJUNCTIVE COILING OCCURRED IN 2 ANEURYSMS WITH WIDE NECKS. THERE WAS 1 MORTALITY IN A PATIENT (6.3%) WHO EXPERIENCED POSTERIOR CEREBRAL ARTERY AND CEREBELLAR STROKES AS WELL AS SUBARACHNOID HEMORRHAGE AFTER THE PLACEMENT OF A FLOW DIVERTER. MINOR COMPLICATIONS OCCURRED IN 2 PATIENTS (12.5%). CONCLUSION: FLOW DIVERSION FOR THE TREATMENT OF BASILAR APEX ANEURYSMS RESULTS IN ACCEPTABLE OCCLUSION RATES IN HIGHLY SELECTED CASES. BOTH PRIMARY FLOW DIVERSION AND RESCUE AFTER FAILED CLIPPING OR COILING RESULTED IN A MODIFIED RANKIN SCALE SCORE THAT WAS EITHER EQUAL OR BETTER THAN AT PRESENTATION AND THE TECHNOLOGY REPRESENTS A VIABLE ALTERNATIVE OR ADJUNCTIVE OPTION. REPORTED EVENTS. - A (B)(6) YEAR OLD FEMALE WAS UNDERGOING SURGERY TO TREAT A SACCULAR ANEURYSM WITH A MAXIMUM DIMENSION OF 25 MM. THE PATIENT EXPERIENCED SUBARACHNOID HEMORRHAGE AFTER THE PLACEMENT OF A SINGLE FLOW DIVERTER AND DID NOT SURVIVE. IN THIS PATIENT, THE RIGHT POSTERIOR CEREBRAL AND BOTH SUPERIOR CEREBELLAR ARTERIES WERE COVERED, BUT DEMONSTRATED FILLING INTRAPROCEDURALLY. WHILE THE ANEURYSM SHOWED PROGRESSIVE THROMBOSIS ON POSTPROCEDURAL DAY 4 CTA, AND THE PATIENT WAS NEUROLOGICALLY INTACT, THE PATIENT LOST CONSCIOUSNESS IMMEDIATELY FOLLOWING IMAGING AND REPEAT CT SHOWED DIFFUSE SUBARACHNOID HEMORRHAGE FROM WHICH SHE EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563717 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE NOT-REP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death