BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVIVE SE 4.5MM OUS

    MDR report key: 10006239 · Received April 28, 2020

    Report

    Report Number
    3008114965-2020-00148
    Event Type
    Death
    Date Received
    April 28, 2020
    Date of Event
    May 31, 2018
    Report Date
    April 9, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DXE
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION.  INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. CERENOVUS MANUFACTURER'S REPORT NUMBERS: 3008114965-2020-00146; 3008114965-2020-00147; 3011370111-2020-00032; 3008114965-2020-00148; 3011370111-2020-00033. ARE RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿A TECHNICAL REPORT ON THE PERFORMANCE OF A NEW LARGE BORE CEREBRAL ASPIRATION CATHETER, THE FIRST RESULTS¿ 2 PATIENTS WITH ACUTE ISCHEMIC STROKE OF THE ANTERIOR CIRCULATION WHO UNDERWENT THE ENDOVASCULAR PROCEDURE WITH STENT RETRIEVER (COMBINATION GROUP) EXPERIENCED SYMPTOMATIC INTRACRANIAL HEMORRHAGE DIED AT 90-DAY FOLLOW-UP. OBJECTIVE: THE INITIAL RESULTS OF THE SYPHONTRACK SUPER DISTAL ACCESS (SDA) CATHETER USED FOR ENDOVASCULAR TREATMENT OF PATIENTS WITH ACUTE ISCHEMIC STROKE OF THE ANTERIOR CIRCULATION WERE DESCRIBED. METHODS: A RETROSPECTIVE REVIEW OF PROSPECTIVELY COLLECTED DATA FROM JUNE 2017 TO MAY 2018 WITH DIRECT DISTAL ASPIRATION OR A COMBINATION OF DISTAL ASPIRATION WITH STENT RETRIEVER THROMBECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469446 REVIVE SE 4.5MM OUS EMBOLECTOMY CATHETER DXE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death