BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 4077799 · Received September 10, 2014

    Report

    Report Number
    1226348-2014-00481
    Event Type
    Death
    Date Received
    September 10, 2014
    Date of Event
    June 15, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    DXE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). COMPLAINT CONCLUSION: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. CONTINUED TOTAL OCCLUSION OF AFFECTED ARTERIAL SEGMENT, STOKE, AND DEATH ARE KNOWN POTENTIAL ADVERSE EVENT THAT ARE ASSOCIATED WITH THE REVIVE SE AND ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THE ROOT CAUSE OF THE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, PATIENT AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THE STROKE AND DEATH MAY HAVE BEEN ASSOCIATED WITH THE PRE-EXISTING OCCLUSION OR THE GUIDECATHETER RELATED DISSECTION. ALTHOUGH THE REVIVE SE FUNCTIONED NORMALLY AND REMOVED THE CLOT DURING IN THE FIRST OCCLUSION, ONLY ONE ATTEMPT WAS PERFORMED FOR TREATMENT OF THE SECOND OCCLUSION. BASED ON THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE DEVICE AND THE EVENT. THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. 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 VIA THE (B)(4) STUDY, A REVIVE SE WAS UNABLE TO RETRIEVE THE CLOT, AND THE PATIENT LATER EXPIRED DUE TO WORSENING OF ISCHEMIC STROKE. PRE-OPERATION ANGIOGRAM OF THE MIDDLE CEREBRAL ARTERY SHOWED EVIDENCE OF M1 OCCLUSION, HOWEVER, ONCE TREATMENT STARTED USING THE REVIVE SE (FRS214522C/ T10000), M1 OCCLUSION WAS OPENED WITH FINAL TICI 2B. AFTER OPENING THE M1 OCCLUSION, AN M2 OCCLUSION WAS FOUND, SO THE INVESTIGATOR ATTEMPTED USING THE REVIVE SE FOR TREATMENT OF THE M2 OCCLUSION. THE FIRST ATTEMPT WITH THE REVIVE SE DID NOT SUCCEED IN RETRIEVING THE CLOT WITH FINAL TICI 0. DURING THE SECOND ATTEMPT, DURING PLACEMENT OF A GUIDECATHETER (MERCI 9F AND CERULEAN 6F), AN ARTERY DISSECTION CONTAINING FALSE LUMEN AT THE INTERIOR CAROTID ARTERY OCCURRED. THEREFORE, THE SECOND PASS WITH THE REVIVE SE WAS NOT ATTEMPTED, AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED TO TREAT THE DISSECTION. THE ARTERY WAS OPENED UP BY PTA AND INTRACRANIAL BLOOD FLOW WAS IMPROVED. THE FOLLOWING DAY, THE PATIENT EXPIRED DUE TO COMPRESSION OF CARDIAC/RESPIRATORY CENTER, CAUSED BY BRAIN HERNIATION COMING FROM BRAIN EDEMA DUE TO WORSENING OF ISCHEMIC STROKE. ACCORDING TO THE INVESTIGATOR, THE DISSECTION, AND WORSENING OF STROKE WERE NOT RELATED TO THE REVIVE SE, BUT WAS CAUSE BY WORSENING OF THE PRIMARY DISEASE. IT WAS REPORTED THAT THE DEVICE WAS FUNCTIONING PROPERLY AND THERE WAS NO EVIDENCE OF DAMAGED VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558093 REVIVE - THROMBECTOMY DEVICE MICRUS THROMBECTOMY DXE MICRUS ENDOVASCULAR, LLC T10000

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death