BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 6345261 · Received February 21, 2017

    Report

    Report Number
    2954740-2017-00034
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Date of Event
    June 8, 2016
    Report Date
    February 3, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DXE
    UDI-DI
    00878528000006
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS INITIAL/FINAL MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR# 2954740-2017-00034. THE REVIVE SE IS NOT DISTRIBUTED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE REVIVE PV THAT IS DISTRIBUTED IN THE UNITED STATES. (B)(4). CONCOMITANT MEDICAL PRODUCTS: GUIDING CATHETER (9FR OPTIMO, TOKAI MEDICAL PRODUCT); MICRO CATHETER (LAVER ); SOLITAIRE DEVICE. THE REVIVE SE WILL NOT BE RETURNED AND WITH NO ALLEGED QUALITY ISSUE NO ROOT CAUSE ANALYSIS CANNOT BE PERFORMED. DHR: A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. DEVICE INEFFECTIVENESS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH 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 AVAILABLE INFORMATION SUGGESTS THAT UNDERLYING DISEASE PROCESS, SPECIFICALLY HYPERTENSION AND CARDIOVASCULAR DISEASE, TARGET LESION CHARACTERISTICS AND MEDICATION REGIMEN FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    SYMPTOMATIC CEREBRAL INFARCTION (RE-EMBOLIZATION OF A TREATED VESSEL) WAS REPORTED IN PATIENT POST-TREATMENT WITH REVIVE SE. IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT THE PATIENT HAD A HISTORY OF SEVERE HYPERTENSION AND CARDIOVASCULAR DISEASE. CARDIAC INFARCT WAS UNDER TREATMENT. THE PATIENT ALSO HAS SURGICAL HISTORY OF SUBDURAL HEMATOMA. PATIENT DEVELOPED CEREBRAL INFARCTION WITH LEFT MIDDLE CEREBRAL ARTERY OCCLUSION (M1D) ON (B)(6) 2016. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2016. BEFORE THE PROCEDURE, NIHSS WAS 6 POINTS. THE VESSELS WERE MODERATELY TORTUOUSNESS AT THE OCCLUDED SITE, THE LENGTH OF THE OCCLUDED SITE WAS UNKNOWN. THE T-PA WAS UNAPPLIED. THE PUNCTURE TIME WAS 4:45 AM. REVIVE SE WAS DEPLOYED TWICE AT THE LESION, TICI: 2A POINTS WAS OBTAINED (6:23 AM). ANOTHER THROMBECTOMY DEVICE (COMPETITOR¿S DEVICE) WAS DEPLOYED 3 TIMES AND TICI:2B WAS OBTAINED. THE PROCEDURE WAS COMPLETED (7:39 AM THE GUIDING SYSTEM WAS REMOVED). NISS WAS 7 POINTS IMMEDIATELY AFTER THE PROCEDURE. 6 HOURS AFTER THE PROCEDURE, PATIENT STATUS HAD DECLINED. RIGHT PARESTHESIA DETERIORATED AND SYMPTOMATIC CEREBRAL INFARCTION (RE-EMBOLIZATION OF TREATED VESSEL: ATHEROTHROMBOTIC) WAS CONFIRMED. PTA WAS PERFORMED BY BALLOON CATHETER. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128067 REVIVE - THROMBECTOMY DEVICE EMBOLECTOMY CATHETER DXE MEDOS INTERNATIONAL SARL NA T10087 00878528000006

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR