BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 6176616 · Received December 15, 2016

    Report

    Report Number
    2954740-2016-00315
    Event Type
    Death
    Date Received
    December 15, 2016
    Date of Event
    July 10, 2016
    Report Date
    December 1, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DXE
    UDI-DI
    00878528000006
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF ONE INITIAL/FINAL MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR# 2954740-2016-00315. THE REVIVE SE IS NOT DISTRIBUTED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE REVIVE PV THAT IS DISTRIBUTED IN THE UNITED STATES. (B)(4). CONCOMITANT MEDICAL PRODUCTS: TRANSCEND GUIDEWIRE 0.014 IN; PROWLER SELECT PLUS CATHETER 0.021; BENCHMARK INTERMEDIATE CATHETER; SOLITAIRE DEVICE. (B)(4). THE REVIVE SE WILL NOT BE RETURNED AND WITH NO ALLEGED QUALITY ISSUE THE ROOT CAUSE ANALYSIS CANNOT BE PERFORMED. DHR: 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. DEVICE INEFFECTIVE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE CODMAN REVIVE SE PRODUCT AND IS LISTED IN THE IFU AS SUCH. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT THROMBUS COMPOSITION MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS IS A CORRECTION FOR MEDWATCH FIELDS. THIS EVENT INVOLVED A DEATH AND THOSE FIELDS WERE ACCIDENTALLY OMITTED.  THEY HAVE BEEN ADDED IN THIS REPORT TO REFLECT THE DEATH EVENT. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE.     MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY (B)(6) STUDY, SUBJECT (B)(6) UNDERWENT COMBINED PROTOCOL OF RTPA AND THROMBECTOMY ON (B)(6) 2016. PRE-TREATMENT MAGNETIC RESONANCE IMAGING REVEALED A THROMBUS LOCATED IN RIGHT MIDDLE CEREBRAL ARTERY (MCA). DIAMETER OF THE ARTERY DISTAL TO THE THROMBUS WAS 18 MM AND PROXIMAL TO THE THROMBUS WAS 20 MM; LENGTH OF THE THROMBUS IN THE PARENT VESSEL WAS 24 MM. RT-PA GIVEN PRE-ANGIO AT A DOSE OF 0.9 MG/KG; NO IA OR IV LYTIC GIVEN INTRA PROCEDURALLY. SYRINGE ASPIRATION VIA AN INTERMEDIATE CATHETER (COMPETITOR¿S DEVICE) WAS PERFORMED. TWO PASSES WERE MADE WITH REVIVE SE (FRS21452299/T10091) TO CLEAR THE CLOT FROM THE CAGE (PARTIAL THROMBECTOMY). NO RECANALIZATION OF MCA WAS ACHIEVED WITH THE REVIVE DEVICE, ANOTHER STENT RETRIEVER WAS USED TO RECANALIZE. TICI SCORE PREPROCEDURE: TICI 0 TICI SCORE POSTREVIVE SE : TICI 0 AND AT THE END OF PROCEDURE : TICI 2B. PATIENT SUFFERED RIGHT MCA STROKE ON (B)(6) 2016 THAT LED TO PATIENT DEATH ON (B)(6) 2016. THE ADVERSE EVENT OF REVIVE SE MALFUNCTION LEADING TO NO RECANALIZATION WAS REPORTED TO BE MILD IN SEVERITY AND NOT A SERIOUS ADVERSE EVENT. THE EVENT WAS REPORTED TO BE RELATED TO THE DEVICE AND UNRELATED TO THE PROCEDURE, THE MEDICATION OR THE UNDERLYING DISEASE STATE. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2016. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827408 REVIVE - THROMBECTOMY DEVICE EMBOLECTOMY CATHETER DXE MEDOS INTERNATIONAL SARL NA T10099 00878528000006

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R