BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 6136149 · Received November 30, 2016

    Report

    Report Number
    2954740-2016-00291
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    September 22, 2016
    Report Date
    November 22, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DXE
    UDI-DI
    00878528000006
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF ONE INITIAL/FINAL MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR# 2954740-2016-00291. (B)(4).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. THE REVIVE WILL NOT BE RETURNED AND NO QUALITY ISSUE WAS ALLEGED, THEREFORE NO ROOT CAUSE ANALYSIS CAN BE PERFORMED. DHR: A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (T10110) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. HEMORRHAGE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE REVIVE SE DEVICE AS 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 THE UNDERLYING DISEASE PROCESS OF ISCHEMIC THROMBOTIC STROKE MAY HAVE CONTRIBUTED THE HEMORRHAGE POST INDEX PROCEDURE; HEMORRHAGIC TRANSFORMATION IS A KNOWN PHENOMENON AFTER ISCHEMIC STROKE EVENTS. NO FURTHER ACTIONS ARE NEEDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS IS FOLLOW-UP REPORT BEING SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR# 2954740-2016-00291. 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. DEVICE INEFFECTIVENESS AND ASYMPTOMATIC INTRACRANIAL HEMORRHAGE WAS REPORTED POST-OPERATIVE IN REVIVE SE PMS STUDY, PATIENT# (B)(6) ON (B)(6) 2016 WHO UNDERWENT PROCEDURE USING REVIVE SE (FRS21452299/ T10110) THROMBECTOMY DEVICE. IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT PATIENT DEVELOPED CEREBRAL INFARCTION DUE TO OCCLUSION IN THE RIGHT MIDDLE CEREBRAL ARTERY ON (B)(6) 2016 AT 10:50 AM. THE MRS LEVEL OF THE PATIENT WAS 1 BEFORE THE CEREBRAL INFARCTION. THE PATIENT ARRIVED AT THE HOSPITAL 11:25 AM. THE LEVEL OF ASPECTS-DWI WAS 3, NIHSS WAS 20, AND TICI WAS 0 BEFORE OPERATION. ALSO, THE DIAMETER OF THE BLOOD VESSEL WHERE THE OCCLUSION OCCURRED WAS 2.06MM AT THE PROXIMAL PORTION AND 1.24MM AT THE DISTAL PORTION. THE LENGTH OF THE OCCLUSION WAS 12.31MM. AT 12:15P.M THE T-PA WAS ADMINISTERED BUT IT WAS NOT RECANALIZED, SO THE REVIVE SE WAS USED FOR THE PROCEDURE. AT 12:24 PM THE PROCEDURE WAS INITIATED AND PUNCTURE WAS MADE. A GUIDING CATHETER (9F OPTIMO, TOKAI MEDICAL PRODUCT) WAS INSERTED AT 12:29 A. M. AND A MICRO CATHETER (MARKSMAN, MEDTRONIC) WAS INSERTED A. M. THE REVIVE SE (COMPLAINT PRODUCT) WAS DELIVERED TO THE LESION AT 12:55 AND DEPLOYED. HOWEVER THERE WAS NO CHANGE OBSERVED IN TICI LEVEL; LEVEL 0. THEREFORE A THROMBUS REMOVAL CATHETER (PENUMBRA SYSTEM, MEDICO'S HIRATA) REPLACED THE COMPLAINT PRODUCT, AND THEN TICI LEVEL 3 WAS OBSERVED AT 1:14 P. M. THE PROCEDURE COMPLETED. ON (B)(6) 2016 THE ASPECTS-CT WAS THE NIHSS LEVEL WAS 19 AFTER THE PROCEDURE. MRI CONFIRMED AN ASYMPTOMATIC INTRACRANIAL HEMORRHAGE (ASYMPTOMATIC SUBARACHNOID HEMORRHAGE). THE DEVELOPED DATE AND TIME IS UNKNOWN. A CONSERVATIVE TREATMENT WAS MADE. THE BLEEDING PART WAS WHERE THE COMPLAINT STENT HAD BEEN DEPLOYED. ON (B)(6) 2016 NIHSS WAS REPORTED TO BE 13. ON (B)(6) 2016 ASPECTS-CT WAS 1 AND ASPECTS-DWI WAS LEFT HEMIPLEGIA WAS REPORTED IN PATIENT ON (B)(6) 2016. PATIENT IS UNDER OBSERVATION. PRODUCT IS NOT AVAILABLE FOR RETURN. CONCOMITANT PRODUCTS: GUIDING CATHETER (9F OPTIMO, TOKAI MEDICAL PRODUCT); MICRO CATHETER (MARKSMAN, MEDTRONIC); THROMBUS REMOVAL CATHETER (PENUMBRA SYSTEM, MEDICO'S HIRATA). THE REVIVE WILL NOT BE RETURNED AND NO QUALITY ISSUE WAS ALLEGED, THEREFORE NO ROOT CAUSE ANALYSIS CAN BE PERFORMED. DHR: A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (T10110) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. DEVICE INEFFECTIVENESS AND HEMORRHAGE ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF 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 THE UNDERLYING DISEASE PROCESS OF ISCHEMIC THROMBOTIC STROKE MAY HAVE CONTRIBUTED THE HEMORRHAGE POST INDEX PROCEDURE; HEMORRHAGIC TRANSFORMATION IS A KNOWN PHENOMENON AFTER ISCHEMIC STROKE EVENTS. THROMBUS CONFORMATION AND CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE DEVICE INEFFECTIVENESS. NO FURTHER ACTIONS ARE NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    ASYMPTOMATIC INTRACRANIAL HEMORRHAGE WAS REPORTED POST-OPERATIVE IN (B)(6) STUDY, PATIENT# (B)(6) ON (B)(6) 2016 WHO UNDERWENT PROCEDURE USING REVIVE SE (FRS21452299/ T10110) THROMBECTOMY DEVICE. IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT PATIENT DEVELOPED CEREBRAL INFARCTION DUE TO OCCLUSION IN THE RIGHT MIDDLE CEREBRAL ARTERY ON (B)(6) 2016 AT 10:50 AM. THE PATIENT ARRIVED AT THE HOSPITAL 11:25 AM. THE LEVEL OF ASPECTS-DWI WAS 3, NIHSS WAS 20, AND TICI WAS 0 BEFORE OPERATION. ALSO, THE DIAMETER OF THE BLOOD VESSEL WHERE THE OCCLUSION OCCURRED WAS 2.06MM AT THE PROXIMAL PORTION AND 1.24MM AT THE DISTAL PORTION. THE LENGTH OF THE OCCLUSION WAS 12.31MM. AT 12:24 PM THE PROCEDURE WAS INITIATED AND PUNCTURE WAS MADE. REPLACED THE COMPLAINT PRODUCT, AND THEN TICI LEVEL 3 WAS OBSERVED AT 1:14 P. M. PROCEDURE WAS COMPLETED. THE NIHSS LEVEL WAS 19 AFTER THE PROCEDURE. MRI CONFIRMED AN ASYMPTOMATIC INTRACRANIAL HEMORRHAGE (ASYMPTOMATIC SUBARACHNOID HEMORRHAGE). THE DEVELOPED DATE AND TIME IS UNKNOWN. A CONSERVATIVE TREATMENT WAS MADE. THE BLEEDING PART WAS WHERE THE COMPLAINT STENT HAD BEEN DEPLOYED. ON (B)(6) 2016 NIHSS WAS REPORTED TO BE 13. ON (B)(6) 2016 ASPECTS-CT WAS 1 AND ASPECTS-DWI WAS 2. LEFT HEMIPLEGIA WAS REPORTED IN PATIENT ON (B)(6) 2016. PATIENT IS UNDER OBSERVATION. PRODUCT IS NOT AVAILABLE FOR RETURN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786885 REVIVE - THROMBECTOMY DEVICE EMBOLECTOMY CATHETER DXE MEDOS INTERNATIONAL SARL NA T10110 00878528000006

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention