BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 6204986 · Received December 27, 2016

    Report

    Report Number
    2954740-2016-00328
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    November 22, 2016
    Report Date
    December 1, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DXE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SYNCHRO STANDARD 0.014 IN, HEADWAY MC 0.021, EMBOTRAP 5 X 22, MICROVENTION SOFIA, INTRAVENOUS TPA. THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.. CONCLUSION: AS REPORTED VIA THE RE-ACT STUDY, A REVIVE SE (FRS21452299/ S10759) FAILED TO RECANNLIZE THE THROMBUS FOR PATIENT (B)(6). THE PATIENT HAD PRESENTED WITH CLINICAL SIGNS CONSISTENT WITH ACUTE ISCHEMIC STROKE, WITH NIH STROKE SCALE SCORE (NIHSS) OF 12. MRI REVEALED RIGHT MIDDLE CEREBRAL ARTERY (M1) THROMBUS. INITIAL THERAPEUTIC STRATEGY ADOPTED BY THE NEUROLOGIST WAS IV TPA AND THROMBECTOMY. THERE WERE 2 PASSES OF THE REVIVE SE FOR REPOSITIONING, AND THE BASKET WAS PULLED UP TO THE INTERMEDIATE CATHETER AND BOTH REMOVED TOGETHER THROUGH THE PRIMARY GUIDE. IT WAS REPORTED THAT PROCEDURAL TECHNICAL COMPLICATION WAS OBSERVED, BUT THERE WERE NO ADVERSE EVENTS. PRE-REVIVE SE TICI WAS 0 AND POST- REVIVE SE TICI WAS 0. TECHNICAL ASSISTANCE WAS USED (PUMP ASPIRATION WITH MICROVENTIONS SOFIA) AND FINAL TICI WAS 3. AT THE TIME OF THE 24 HOUR FOLLOW-UP, NIHSS WAS NOT DONE; HOWEVER THERE WAS NO INTRACRANIAL HEMORRHAGE NOTED AND NO ADVERSE EVENTS. THE PATIENT WAS DISCHARGED AFTER 9 DAYS WITH AN MRS SCORE OF 2 (SLIGHT DISABILITY, UNABLE TO CARRY OUT ALL PREVIOUS ACTIVITIES, BUT ABLE TO LOOK AFTER OWN AFFAIRS WITHOUT ASSISTANCE). NIHSS WAS 0 AT DISCHARGE. 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. CONTINUED TOTAL OCCLUSION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE REVIVE SE. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, PROCEDURAL/PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. AS PER THE IFU: ¿CONTRAINDICATIONS FOR THIS DEVICE INCLUDE EXTREME VESSEL TORTUOSITY OR OTHER CONDITIONS PREVENTING THE ACCESS OF THE DEVICE¿. THE IFU ALSO WARNS THAT ¿IF THE REVIVE SE DEVICE IS UNABLE TO REACH OR CROSS THE OCCLUSION, THE PROCEDURE SHOULD BE TERMINATED.¿ SINCE THERE WAS NO EVIDENCE TO SUGGEST 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 U.S.; HOWEVER, IT IS SIMILAR TO THE REVIVE PV WHICH IS DISTRIBUTED IN THE U.S. THIS IS AN INITIAL/FINAL MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED VIA THE RE-ACT STUDY, A REVIVE SE (FRS21452299/ S10759) FAILED TO RECANALIZE THE THROMBUS FOR PATIENT (B)(6). THE PATIENT HAD PRESENTED WITH CLINICAL SIGNS CONSISTENT WITH ACUTE ISCHEMIC STROKE, WITH NIH STROKE SCALE SCORE (NIHSS) OF 12. MRI REVEALED RIGHT MIDDLE CEREBRAL ARTERY (M1) THROMBUS. INITIAL THERAPEUTIC STRATEGY ADOPTED BY THE NEUROLOGIST WAS IV TPA AND THROMBECTOMY. THERE WERE 2 PASSES OF THE REVIVE SE FOR REPOSITIONING, AND THE BASKET WAS PULLED UP TO THE INTERMEDIATE CATHETER AND BOTH REMOVED TOGETHER THROUGH THE PRIMARY GUIDE. IT WAS REPORTED THAT PROCEDURAL TECHNICAL COMPLICATION WAS OBSERVED, BUT THERE WERE NO ADVERSE EVENTS. PRE-REVIVE SE TICI WAS 0 AND POST- REVIVE SE TICI WAS 0. TECHNICAL ASSISTANCE WAS USED (PUMP ASPIRATION WITH MICROVENTIONS SOFIA) AND FINAL TICI WAS 3. AT THE TIME OF THE 24 HOUR FOLLOW-UP, NIHSS WAS NOT DONE; HOWEVER THERE WAS NO INTRACRANIAL HEMORRHAGE NOTED AND NO ADVERSE EVENTS. THE PATIENT WAS DISCHARGED AFTER 9 DAYS WITH AN MRS SCORE OF 2 (SLIGHT DISABILITY, UNABLE TO CARRY OUT ALL PREVIOUS ACTIVITIES, BUT ABLE TO LOOK AFTER OWN AFFAIRS WITHOUT ASSISTANCE. NIHSS WAS 0 AT DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857789 REVIVE - THROMBECTOMY DEVICE EMBOLECTOMY CATHETER DXE MEDOS INTERNATIONAL SARL NA S10759

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTINUED ON H10