BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 6134915 · Received November 30, 2016

    Report

    Report Number
    2954740-2016-00289
    Event Type
    Death
    Date Received
    November 30, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 10, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DXE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUED FROM SECTION D11: SYNCHRO STANDARD 0.014, HEADWAY 21 0.021. (B)(4). CONCLUSION: THE DEVICE WAS NOT AVAILABLE 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. STROKE AND HEMORRHAGE ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH USE OF THE REVIVE SE AND ARE LISTED IN THE IFU AS SUCH. THE ROOT CAUSE OF THE HEMORRHAGIC TRANSFORMATION COULD NOT BE DETERMINED WITHOUT PROCEDURE FILMS TO REVIEW; HOWEVER, THE PATIENT¿S PRE-EXISTING CONDITION (PRESENTED WITH RANKIN SCORE OF 20), THROMBOLYTIC THERAPY AND PATIENT HISTORY OF HYPERTENSION MAY HAVE CONTRIBUTED TO THE EVENT. THERE WERE NO PROCEDURAL TECHNICAL COMPLICATIONS AND NO PROCEDURAL ADVERSE EVENTS ASSOCIATED WITH THE REVIVE SE. SINCE THERE WAS NO EVIDENCE THAT THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE REVIVE SE IS NOT DISTRIBUTED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE REVIVE PV. THIS IS AN INITIAL/FINAL MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY THE RE-ACT STUDY, PATIENT (B)(6), WITH A HISTORY OF HIGH BLOOD PRESSURE AND DIABETES, EXPIRED DUE TO HEMORRHAGIC TRANSFORMATION OF STROKE WITH ISCHEMIC LESIONS FRONTAL PUNCTURE SHAPE IN THE UPPER RIGHT SIDE AND URINARY/PULMONARY SEPSIS APPROXIMATELY FOUR DAYS AFTER THE SUCCESSFUL USE OF A REVIVE SE (FRS21452299/ S10759). THE PATIENT HAD PRESENTED WITH A MODIFIED RANKIN SCORE OF 20, AND MRI REVEALED LEFT MIDDLE CEREBRAL ARTERY (M1) THROMBUS. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE A STROKE PRIOR TO THE PROCEDURE; HOWEVER, PRESENTED WITH RIGHT CEREBRAL MOTOR DYSFUNCTION. PRE-PROCEDURE, THE PATIENT RECEIVED T-PA 0.9MG/KG INTRAVENOUSLY AND PUMP ASPIRATION WAS ATTEMPTED. TICI WAS 0. FOLLOWING 1 PASS OF THE REVIVE SE, TICI WAS 3. THE BASKET WAS PULLED UP TO THE INTERMEDIATE CATHETER AND THE REVIVE SE AND THE INTERMEDIATE CATHETER WERE BOTH REMOVED TOGETHER THROUGH THE PRIMARY GUIDE. THERE WERE NO PROCEDURAL TECHNICAL COMPLICATIONS OBSERVED, AND NO PROCEDURAL ADVERSE EVENTS. THE FOLLOWING DAY, THE PATIENT EXPERIENCED SEVERE HEMORRHAGIC INFARCT WITH NIHSS OF 23, COMPLETE MOTOR DISORDER RIGHT HEMI-CORPORAL, COMPLETE LATERAL RIGHT HEMIANOPIA, MUTISM, AND DEFLECTION OF THE HEAD AND EYES TO THE LEFT SIDE. CEREBRAL MRI CONFIRMED HEMORRHAGIC TRANSFORMATION, CORTICO SUB-CORTICAL FRONTO PARIETO LEFT TEMPORAL, IN CONTACT WITH LEFT SIDE OF MCA. APPROXIMATELY 2 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED SEVERE URINARY AND PULMONARY INFECTION WITH SEPSIS THAT WAS TREATED WITH AUGMENTIN. IT WAS REPORTED THAT THE HEMORRHAGIC TRANSFORMATION AND INFECTION LEAD TO DEATH APPROXIMATELY 4 DAYS AFTER THE INDEX PROCEDURE. ACCORDING TO THE INVESTIGATOR, THE INFARCT WAS POSSIBLY RELATED TO MEDICATION AND UNDERLYING DISEASE, UNLIKELY RELATED TO THE DEVICE AND UNKNOWN IF RELATED TO THE PROCEDURE. THE SEPSIS WAS POSSIBLY RELATED TO THE UNDERLYING DISEASE AND UNKNOWN IF RELATED TO THE DEVICE, PROCEDURE OR MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786889 REVIVE - THROMBECTOMY DEVICE EMBOLECTOMY CATHETER DXE MEDOS INTERNATIONAL SARL NA S10759

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| H