BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVIVE SE 4.5MM OUS

    MDR report key: 10092607 · Received May 27, 2020

    Report

    Report Number
    3008114965-2020-00206
    Event Type
    Death
    Date Received
    May 27, 2020
    Date of Event
    January 31, 2013
    Report Date
    May 5, 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. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. CERENOVUS MANUFACTURER'S REPORT NUMBERS: 3008114965-2020-00200, 3008114965-2020-00201, 3008114965-2020-00202, 3008114965-2020-00203, AND 3008114965-2020-00205 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, ¿MECHANICAL THROMBECTOMY FOR ISCHAEMIC STROKE: THE FIRST UK CASE SERIES¿ 1 PATIENT WITH ACUTE ISCHEMIC STROKE WHO UNDERWENT ENDOVASCULAR TREATMENT WITH THROMBECTOMY DIED DUE TO RECURRENT STROKE IN THE OTHER HEMISPHERE. PURPOSE: ENDOVASCULAR TREATMENTS HAVE THE POTENTIAL TO ACCELERATE REPERFUSION IN ACUTE ISCHAEMIC STROKE WITH LARGE VESSEL OCCLUSION. RESULTS OF THE FIRST 106 ENDOVASCULAR TREATMENTS (EVT) IN THE UK WERE PRESENTED IN THE ARTICLE. METHODS: FROM DECEMBER 2009 TO JANUARY 2013 106 PATIENTS (MEAN AGE 64 YEARS, MEDIAN BASELINE NIHSS 18) WERE TREATED WITH EVT (THROMBECTOMY ± IAT 83%, IAT (INTRA-ARTERIAL THROMBOLYSIS) ALONE 13%, NEITHER 4%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557097 REVIVE SE 4.5MM OUS EMBOLECTOMY CATHETER DXE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death