BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 5794046 · Received July 14, 2016

    Report

    Report Number
    2954740-2016-00148
    Event Type
    Death
    Date Received
    July 14, 2016
    Date of Event
    September 25, 2015
    Report Date
    July 1, 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

    THE REVIVE SE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO THE REVIVE PV THAT IS DISTRIBUTED IN THE UNITED STATES. (B)(4). CONCLUSION: THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (T10068) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. DISTAL EMBOLIZATION OF THROMBUS IS A KNOWN COMPLICATION WITH USE OF THE REVIVE SE, AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONFIRMED WITHOUT PROCEDURAL FILMS TO REVIEW; HOWEVER, BASED ON THE INFORMATION PROVIDED, PROCEDURAL/PATIENT FACTORS (CLOT LONGER THEN THE REVIVE SE) MAY HAVE CONTRIBUTED TO THE EVENT. THERE WAS NO EVIDENCE THAT THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, AND THE PHYSICIAN REPORTED THERE WAS NO DEVICE FAILURE OR MALFUNCTION. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT.

    Additional Manufacturer Narrative · 1

    THIS EVENT INVOLVED A DEATH AND THIS FIELD WAS ACCIDENTALLY OMITTED.  IT HAS BEEN ADDED IN THIS REPORT TO REFLECT THE DEATH EVENT. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. IN ADDITION DATE OF DEATH (B)(6) 2016 WAS ADDED TO THIS PART. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE RE-ACT STUDY, PATIENT 07-003 EXPERIENCED DISTAL THROMBUS MIGRATION. THE PATIENT LATER EXPIRED DUE TO MASSIVE HEMORRHAGE TRANSFORMATION RELATED TO THE PRE-EXISTING CONDITION. THE PATIENT HAD PRESENTED WITH CLINICAL SIGNS CONSISTENT WITH ACUTE ISCHEMIC STROKE WITH NIH STROKE SCALE SCORE OF 22. IMAGING REVEALED RIGHT MIDDLE CEREBRAL (M1) THROMBUS. THE PATIENT WAS TREATED WITH TPA 16MG/KG. MULTIPLE PASSES WITH THE REVIVE SE (FRS21452299/ T100068) WERE NEEDED TO CLEAR THE CLOT FROM THE CAGE (PARTIAL THROMBECTOMY). A SMALL PART OF THE THROMBUS WAS DISLODGED BY THE REVIVE SE (CLOT WAS LONGER THAN THE FULL LENGTH OF THE REVIVE SE) AND MIGRATED TO THE ANTERIOR CEREBRAL ARTERY (ACA) AND FIXED TO THE A2 SEGMENT. INTRA-ARTERIAL THROMBOLYSIS ALLOWED RECANALIZATION OF THE ACA SEGMENT EXCEPT THE PERICALLEOUS SEGMENT. THE BASKET WAS RECONSTRAINED IN THE MICROCATHETER FOR REMOVAL. IT WAS REPORTED THAT THE DISTAL EMBOLI EVENT RESOLVED WITHOUT SEQUELAE ON THE SAME DAY AS THE PROCEDURE. IT WAS REPORTED THAT THERE WERE NO PROCEDURAL OR TECHNICAL COMPLICATIONS OBSERVED, AND NO DEVICE FAILURE OR MALFUNCTION. PRE-PROCEDURE TICI WAS 0 AND POST-REVIVE SE TICI WAS 1. TICI SCORE AT END OF PROCEDURE WAS TICI 0. ACCORDING TO THE INVESTIGATOR, THE DISTAL EMBOLI WAS UNRELATED TO THE DEVICE, POSSIBLY RELATED TO THE PROCEDURE, AND RELATED TO THE UNDERLYING DISEASE. THE REVIVE SE WAS DISCARDED. IT WAS REPORTED THAT THE DEVICE WAS USED AS PER THE INSTRUCTIONS FOR USE (IFU). IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE EDEMATOUS INFARCTIONS IN THE FULL TERRITORY OF THE LEFT MCA WITH EXTENSIVE HEMORRHAGIC COMPONENTS IN THE ANTERIOR AND DEEP REGIONS THE DAY AFTER THE PROCEDURE, WITH MASSIVE HEMORRHAGE TRANSFORMATION THE FOLLOWING DAY. THE PATIENT EXPIRED APPROXIMATELY 3 DAYS LATER. ACCORDING TO THE INVESTIGATOR, THE HEMORRHAGE WAS UNRELATED TO THE DEVICE AND WAS RELATED TO THE UNDERLYING DISEASE AND PROCEDURE (INTRA-ARTERIAL TPA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447279 REVIVE - THROMBECTOMY DEVICE MICRUS THROMBECTOMY DXE MEDOS INTERNATIONAL SARL T10068

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R PROWLER 27 MICROCATHETER