BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 4078237 · Received September 10, 2014

    Report

    Report Number
    1226348-2014-00488
    Event Type
    Death
    Date Received
    September 10, 2014
    Date of Event
    November 28, 2013
    Report Date
    December 10, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    DXE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MOHLENBRACH, M. ET AL, ¿MECHANICAL THROMBECTOMY WITH STENT RETRIEVERS IN ACUTE BASILAR ARTERY OCCLUSION¿, AJNR AM J NEURORADIO, 2013 NOV 28. COMPLAINT CONCLUSION: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IN ADDITION, THE STERILE LOT NUMBER WERE NOT PROVIDED, THEREFORE, A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, THERE WERE PATIENT FACTORS THAT MAY HAVE CONTRIBUTED TO THE PATIENT¿S DEATH AND TO THE INABILITY TO PASS THE DEVICE THROUGH THE THROMBUS. CONTINUED TOTAL OCCLUSION OF AFFECTED ARTERIAL SEGMENT IS A KNOWN PROCEDURAL COMPLICATION WITH USE OF THE REVIVE SE AND IS LISTED IN THE IFU AS SUCH. NO INFORMATION WAS PROVIDED TO DEMONSTRATE THAT THERE WAS A PROBLEM WITH THE PRODUCT DESIGN OR MANUFACTURING THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT, THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. THIS MDR IS BEING SUBMITTED AS PART OF RETROSPECTIVE REVIEW AND WITH ACCORDANCE TO THE REQUIREMENTS OF CODE OF FEDERAL REGULATIONS - 21 CFR PART 803, MEDICAL DEVICE REPORTING. REVIVE SE IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED REVIVE PV.

    Description of Event or Problem · 1

    AS REPORTED IN A GERMAN LITERATURE ARTICLE (MOHLENBRACH, M. ET AL, ¿MECHANICAL THROMBECTOMY WITH STENT RETRIEVERS IN ACUTE BASILAR ARTERY OCCLUSION¿, AJNR AM J NEURORADIO, 2013 NOV 28) A PATIENT WITH ACUTE BASILAR ARTERY OCCLUSION AND ACUTE ISCHEMIC STROKE EXPIRED AND THE REVIVE SE THROMBECTOMY DEVICE WAS INEFFECTIVE (STUDY PATIENT #23). THE PATIENT¿S BASELINE TICI WAS 0 AND TICI AT END POINT TICI WAS 0. BASELINE NHISS SCORE WAS NOT REPORTED. THERE HAD BEEN TEN PASSES WITH THE REVIVE SE AND NO STENTS HAD BEEN PLACED. THE PATIENT HAD ALSO BEEN TREATED WITH INTRAVENOUS RTPA. CONCOMITANT MEDICATIONS INCLUDED TIROFIBAN. ACCORDING TO THE PHYSICIAN, THE DEATH WAS NOT RELATED TO THE REVIVE, BUT WAS RELATED TO THE "BAD OUTCOME OF THE PATIENT". NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556838 REVIVE - THROMBECTOMY DEVICE MICRUS THROMBECTOMY DXE MICRUS ENDOVASCULAR, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death