BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE FLEX

    MDR report key: 10916605 · Received November 29, 2020

    Report

    Report Number
    2029214-2020-01201
    Event Type
    Death
    Date Received
    November 29, 2020
    Date of Event
    November 1, 2020
    Report Date
    November 29, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. REFER TO MANUFACTURER REPORT 2029214-2020-01200 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    I. JONATHAN POMERANIEC, PANAGIOTIS MASTORAKOS, DANIEL RAPER, MIN S. PARK, RERUPTURE FOLLOWING FLOW DIVERSION OF A DISSECTING ANEURYSM OF THE VERTEBRAL ARTERY: CASE REPORT AND REVIEW OF THE LITERATURE, WORLD NEUROSURGERY, VOLUME 143, 2020, PAGES 171-179, ISSN 1878-8750, HTTPS://DOI.ORG/10.1016/J.WNEU.2020.07.149. MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH FLOW DIVERSION OF THE ANEURYSM USING OVERLAPPING PIPELINES. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE PIPELINES. THE PATIENT WAS A NONSMOKING, (B)(6) MALE WITH A BODY MASS INDEX OF 31. HE HAD A REMOTE HISTORY OF DYSLIPIDEMIA AND INTERMITTENT PLEURITIC CHEST PAIN ON LOW DOSE BETA BLOCKER. HE EXPERIENCED A SUDDEN ONSET OF HOLOCEPHALIC, SEVERE HEADACHES WITH SUBSEQUENT PROGRESSIVE DECLINE OF MENTAL STATUS. COMPUTED TOMOGRAPHY OF THE HEAD AT PRESENTATION DEMONSTRATED DIFFUSE SUBARACHNOID HEMORRHAGE PREDOMINATELY OF THE FORAMEN MAGNUM WITH EXTENSION INTO THE PREPONTINE CISTERN AND FOURTH AND LATERAL VENTRICLES WITH ATTENDANT ACUTE HYDROCEPHALUS AND PERIVENTRICULAR EDEMA. THE PATIENT UNDERWENT FLOW DIVERSION OF THE ANEURYSM USING OVERLAPPING PIPELINES (PED) (3.0 X 20 AND 3.25 X 20 MM). THE ANEURYSM NECK WAS WELL COVERED WITH THE 2 OVERLAPPING DEVICES. ANGIOGRAPHY SHOWED APPROPRIATE POSITIONING OF THE STENT CONSTRUCT WITH GOOD APPOSITION TO THE WALL. POST-PROCEDURE DAY 2, THE PATIENT EXPERIENCED A SUDDEN DECLINE IN MENTAL STATUS, HYPERTENSION, TACHYCARDIA, HYPOTENSION. NEW INTRAVENTRICULAR HEMORRHAGE, SUBARACHNOID HEMORRHAGE, AND LEFT SUBDURAL HEMATOMA WAS FOUND. THE PATIENT HAD ABSENT COUGH AND GAG REFLEX AND CORNEAL RESPONSE, AS WELL AS NO SPONTANEOUS RESPIRATIONS. THE FAMILY WITHDREW CARE, AND THE PATIENT PASSED ON THE THIRD DAY AFTER THE INITIAL ANEURYSM RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381483 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-325-20

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death