BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 6139099 · Received December 1, 2016

    Report

    Report Number
    2954740-2016-00295
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    January 10, 2016
    Report Date
    November 14, 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

    CONCOMITANT MEDICAL DEVICES: SYNCHRO STANDARD 0.014 IN, PROWLER SELECT PLUS 0.021 TREVO XP, AND PENUMBRA 5 PUMP ASPIRATION CATHETER. (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. 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. THIS IS AN INITIAL/FINAL MDR REPORT. REVIVE SE IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, IT IS SIMILAR TO THE REVIVE PV THAT IS DISTRIBUTED IN THE U.S.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(6) STUDY, THE REVIVE SE ((B)(4)) FAILED TO COMPLETELY RECANALIZE THE ARTERY ON PATIENT (B)(6). THE PATIENT HAD PRESENTED WITH NIHSS 8 WITH CLINICAL SIGNS CONSISTENT WITH ACUTE ISCHEMIC STROKE. MIR REVEALED RIGHT MIDDLE CEREBRAL ARTERY (M1) THROMBUS THAT MEASURED 1 CM IN LENGTH. THE PATIENT WAS INITIALLY TREATED WITH TPA 0.9MG/KG. THERE WAS 1 PASS OF THE REVIVE SE, AND THE BASKET WAS PULLED UP TO THE INTERMEDIATE CATHETER AND BOTH REMOVED TOGETHER THROUGH THE PRIMARY GUIDE. IT WAS REPORTED THAT THERE WAS A PROCEDURAL TECHNICAL COMPLICATION DESCRIBED AS USING THE REVIVE SE DID NOT ALLOW RECANALIZATION, BUT NO ADVERSE EVENT WAS OBSERVED. PRIOR TO REVIVE SE USE, TICI WAS 0, POST-REVIVE TICI WAS 1. AFTER ADDITIONAL TREATMENT WITH TREVO XP AND PENUMBRA 5 PUMP ASPIRATION, TICI WAS 2A. THE INVESTIGATOR DID NOT KNOW WHAT MAY HAVE CONTRIBUTED TO THE INABILITY OF THE REVIVE SE TO RECANALIZE THE VESSEL. THERE WAS RESISTANCE FELT DURING ADVANCEMENT OF THE REVIVE SE THROUGH THE MICROCATHETER THAT WAS RELATED TO VESSEL TORTUOSITY. THE REVIVE SE WAS USED AND DEPLOYED AS PER THE IFU. ACCORDING TO THE INVESTIGATOR, THE INCOMPLETE RECANALIZATION WAS MODERATELY SEVERE, NOT SERIOUS, RELATED TO THE DEVICE AND PROCEDURE, AND UNRELATED TO THE UNDERLYING DISEASE. THE EVENT RESOLVED ON THE SAME DAY AS THE PROCEDURE. THE DEVICE WAS DISCARDED. AT THE 24 HOUR FOLLOW-UP, NIHSS SCORE WAS 10, WITH NO REPORTED ADVERSE EVENTS. THE PATIENT WAS DISCHARGED AFTER 3 DAYS OF HOSPITALIZATION WITH MODERATE DISABILITY, REQUIRED SOME HELP, BUT ABLE TO WALK WITHOUT ASSISTANCE. NIHSS WAS 9. AT THE 90 DAY FOLLOW-UP, NIHSS WAS 9 AND MRS WAS 2 (SLIGHT DISABILITY, UNABLE TO CARRY OUT ALL PREVIOUS ACTIVITIES, BUT ABLE TO LOOK AFTER OWN AFFAIRS WITHOUT ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789598 REVIVE - THROMBECTOMY DEVICE EMBOLECTOMY CATHETER DXE MEDOS INTERNATIONAL SARL NA T10082

    Patients

    Seq Age Sex Outcome Treatment
    1