BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN NV PRODUCT

    MDR report key: 11033907 · Received December 17, 2020

    Report

    Report Number
    2029214-2020-01336
    Event Type
    Death
    Date Received
    December 17, 2020
    Date of Event
    May 19, 2018
    Report Date
    December 17, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT. 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. PRODUCT CODE MAY ALSO BE OUT. THE ARTICLE DOES NOT STATE WHICH DEVICE WAS USED IN THE 2 PATIENTS WHO DIED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    COHEN JE, GOMORI JM, LEKER RR, SPEKTOR S, ABU EL HASSAN H, ITSHAYEK E. STENT AND FLOW DIVERTER ASSISTED TREATMENT OF ACUTELY RUPTURED BRAIN ANEURYSMS. JOURNAL OF NEUROINTERVENTIONAL SURGERY. 2018;10(9):851-858. DOI:10.1136/NEURINTSURG-2017-013742 MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH STENT AND FLOW DIVERTER ASSISTED TREATMENT OF ACUTELY RUPTURED BRAIN ANEURYSM. THE NEUROENDOVASCULAR DEVICES USED IN THE PATIENT WAS AT THE DISCRETION OF THE NEUROSURGEON WHICH INCLUDED BOTH MEDTRONIC DEVICES AND NON-MEDTRONIC DEVICES. THE ARTICLE DOES NOT DIFFERENTIATE PATIENT ADVERSE EVENTS WITH THE TYPE OF DEVICE IMPLANTED. THE PURPOSE OF THIS ARTICLE WAS RETROSPECTIVELY REVIEW CLINICAL RECORDS OF PATIENTS TREATED BY STENT TECHNIQUES DURING THE EARLY ACUTE PHASE OF ANEURYSMAL RUPTURE. THE AUTHORS REVIEWED 47 CASES OF PATIENTS: THE AVERAGE AGE WAS 38 YEARS, 20 WERE FEMALE AND 27 WERE MALE. 42/45 PATIENTS PRESENTED WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 0-2 AT THE 9-12 MONTH FOLLOW-UP. THERE WERE NO POST-PROCEDURE HEMORRHAGIC COMPLICATIONS. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE SOLITAIRE OR FLOW DIVERTER. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: 1. 2 PATIENTS DIED. NO INFORMATION WAS PROVIDED ON RELATEDNESS OR CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498697 UNKNOWN NV PRODUCT CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death