BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM ATLAS

    MDR report key: 11300551 · Received February 9, 2021

    Report

    Report Number
    11300551
    Event Type
    Death
    Date Received
    February 9, 2021
    Date of Event
    November 12, 2020
    Report Date
    February 4, 2021
    Manufacturer
    STRYKER NEUROVASCULAR
    Product Code
    QCA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FEMALE PRESENTING FOR ELECTIVE STENT ASSISTED COIL EMBOLIZATION OF R ICA ANEURYSM. PROCEDURE COMPLICATED BY STENT FAILURE AND INABILITY TO EMBOLIZE ANEURYSM WITH SUBSEQUENT RUPTURE. PROCEDURE ALSO COMPLICATED BY SUBSEQUENT R PCA AND R SCA INFARCTION (DIFFERENT VESSEL THAN TREATED DURING PROCEDURE). AN ATLAS STENT WAS INITIALLY PLACED IN RIGHT ICA FOR STENT COILING, BUT IT DEFORMED WHEN COILING WAS ATTEMPTED. WE THEN PLACED AN LVIIS BLUE STENT AFTER ATTEMPTS TO RETRIEVE THE ATLAS FAILED. PATIENT WAS GIVEN AN INTEGRILLIN BOLUS AND INFUSION. SHEATHS WERE LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200288 NEUROFORM ATLAS INTRACRANIAL COIL-ASSIST STENT QCA STRYKER NEUROVASCULAR M003UZAS40240 21601235

    Patients

    Seq Age Sex Outcome Treatment
    1 13140 DA Death