BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 5400033 · Received January 29, 2016

    Report

    Report Number
    1226348-2016-00013
    Event Type
    Injury
    Date Received
    January 29, 2016
    Date of Event
    June 12, 2015
    Report Date
    January 7, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DXE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING TREATMENT OF THIS (B)(4) STUDY PATIENT, (B)(6), THERE WAS RESISTANCE/FRICTION WITH THE REVIVE SE DEVICE (FRS21452299/T10045) AND THE REBAR TM-27 MICROCATHETER (105-5082-145/A044980) AND THEN FAILURE TO REMOVE THE CLOT AFTER SEVERAL PASSES AND USE OF SEVERAL DEVICES: SOLITAIRE FR (SRD-6-30/A061511) AND MEDICAL CONCENTRIC TREVO XP PROVUE (90182/37328). REQUIRED PROLONGATION OF EXISTING HOSPITALIZATION. IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED FOR ANALYSIS. A CONTINUOUS ADEQUATE FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS A MILD DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WAS NO PATIENT INJURY. THE CLOT WAS NOT EVENTUALLY REMOVED. THE REVIVE SE WILL NOT BE RETURNED, THEREFORE THE ROOT CAUSE OF THE RESISTANCE AND THE FAILURE TO REMOVE THE CLOT CANNOT BE DETERMINED. DHR: A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (T10045) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. FAILURE TO REMOVE THROMBUS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH USE OF THE REVIVE SE DEVICE AND IS LISTED IN THE IFU AS SUCH. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. REVIEW OF THE LIMITED INFORMATION SUGGESTS THAT LENGTH IF TIME SINCE THROMBUS FORMATION, PATIENT ANATOMY AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. UDI: UNKNOWN PART NUMBER, ALL 3 ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL, UDI UNAVAILABLE. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: MICROCATHETER (DETAILS UNKNOWN).

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER UPDATED

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED STATES THAT DURING TREATMENT OF THIS RE-ACT STUDY PATIENT, (B)(6), THERE WAS RESISTANCE/FRICTION WITH THE REVIVE SE DEVICE (DETAILS UNKNOWN) AND THE MICROCATHETER (DETAILS UNKNOWN) AND THEN FAILURE TO REMOVE THE CLOT AFTER SEVERAL PASSES AND USE OF SEVERAL DEVICES. REQUIRED PROLONGATION OF EXISTING HOSPITALIZATION. IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58096 REVIVE - THROMBECTOMY DEVICE MICRUS THROMBECTOMY DXE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization