BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 6180658 · Received December 16, 2016

    Report

    Report Number
    2954740-2016-00309
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    September 15, 2016
    Report Date
    November 22, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DXE
    UDI-DI
    00878528000006
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP MDR IS BEING SUBMITTED FOR ASSOCIATED MFR #2954740-2016-00309. UPDATE (B)(6) 2017: BEFORE DEVELOPMENT, MRS WAS 0 POINTS. THE REVIVE SE WAS DEPLOYED WITH A CATHETER (PENUMBRA, MEDICO'S HIRATA) AT THE BLOCKADE PART, BUT THERE WERE NO CHANGES IN TICI:0 POINT(9:33AM), SO ONLY PENUMBRA WAS USED AND TCIC;0POINT WAS OBTAINED (9:56AM). THE GUIDING SYSTEM WAS REMOVED AT 10:59AM.

    Additional Manufacturer Narrative · 1

    THIS WILL BE 1 OF 1 INITIAL/FINAL REPORT SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR #2954740-2016-00309. REVIVE SE IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, IT IS SIMILAR TO REVIVE PV THAT IS DISTRIBUTED IN THE U.S (B)(4). CONCOMITANT MEDICAL DEVICE: GUIDING CATHETER (9FR OPTIMO, TOKAI MEDICAL PRODUCT), MICRO CATHETER (MARKSMAN, MEDTRONIC), PENUMBRA (MEDICO'S HIRATA). (B)(4). BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE REVIVE SE WILL NOT BE RETURNED AND WITH NO QUALITY ISSUE REPORTED, THE 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. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. DEVICE INEFFECTIVE AND HEMORRHAGE ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE REVIVE SE DEVICE AND ARE 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 TARGET LESION, MEDICATION REGIMEN AND THROMBUS CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THE PATIENT HAD A SYMPTOMATIC INTRACRANIAL/SUBARACHNOID HEMORRHAGE FOLLOWING A THROMBECTOMY PROCEDURE USING A REVIVE SE ((B)(4)). THIS IS A (B)(6) YEAR OLD MALE ((B)(6)) WITH A HISTORY OF HIGH BLOOD PRESSURE AND DIVERTICULAR HEMORRHAGE. ON (B)(6) 2016 AT 6:30AM, THE PATIENT DEVELOPED THE CEREBRAL INFARCTION WITH THE RIGHT OCCLUSION OF THE MIDDLE CEREBRAL ARTERY (M2) BLOCKADE. THE PATIENT WAS HOSPITALIZED AT 8:30AM ON (B)(6) 2016. PRIOR TO THE THROMBECTOMY PROCEDURE, ASPECTS-CT: 5 POINTS, NIHSS: 7 POINTS, AND TICI: 0 POINTS. THE VASCULAR DIAMETER OF THE BLOCKED PORTION OF THE VESSEL WAS 2.06MM PROXIMAL, 1.62MM DISTAL, AND 9MM IN LENGTH. THE T-PA WAS NOT ADMINISTERED, SO THE REVIVE SE (COMPLAINT PRODUCT) WAS USED DURING THE PROCEDURE. AT 8:58AM, THE PUNCTURE WAS MADE. A GUIDING CATHETER (9FR OPTIMO, TOKAI MEDICAL PRODUCT (INSERTED AT 9:05AM)) AND A MICRO CATHETER (MARKSMAN, MEDTRONIC(INSERTED AT 9:25AM)) WERE ALSO USED FOR THE PROCEDURE. THE REVIVE SE WAS DEPLOYED WITH A CATHETER (PENUMBRA, MEDICO'S HIRATA) AT THE BLOCKADE, BUT THERE WERE NO CHANGES; TICI WAS 0 POINTS AT 9:22AM. THEREFORE, PTA WAS PERFORMED 3 TIMES AND TICI: 2B WAS OBTAINED AT 10:54AM TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, NIHSS WAS 20 POINTS. THE INTRACRANIAL BLEEDING (SAH) WAS FOUND APPROXIMATELY 24 HOURS POST PROCEDURE. BLEEDING WAS LATER CONFIRMED TO HAVE IMPROVED AS A RESULT OF CONSERVATIVE TREATMENT. ON (B)(6)2016, MRS: 4POINTS AND NIHSS: 11 POINTS. IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT REMAINED IMPAIRED WITH A HEADACHE, DISTURBANCE OF CONSCIOUSNESS AND A LEFT TORPOR. THE PATIENT IS BEING FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832768 REVIVE - THROMBECTOMY DEVICE EMBOLECTOMY CATHETER DXE MEDOS INTERNATIONAL SARL NA T10086 00878528000006

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention