BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 6036313 · Received October 18, 2016

    Report

    Report Number
    2954740-2016-00244
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    September 22, 2016
    Report Date
    September 28, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DXE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIVE SE IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, IT IS SIMILAR TO REVIVE PV THAT IS DISTRIBUTED IN THE U.S. UDI: (B)(4). CONCLUSION: THE PROWLER SELECT PLUS AND THE REVIVE SE WERE NOT RETURNED FOR ANALYSIS. THE LOT NUMBER OF THE PROWLER SELECT PLUS WAS NOT PROVIDED; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THE LOT OF THE REVIVE SE PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. DISSECTION AND VESSEL PERFORATION ARE KNOWN POTENTIAL PROCEDURAL EVENTS THAT CAN OCCUR WITH USE OF THE REVIVE SE AND THE PROWLER SELECT PLUS. WITHOUT FILMS TO REVIEW, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT; HOWEVER, THE EVENT MAY HAVE BEEN RELATED TO PROCEDURAL FACTORS, OTHER DEVICES USED DURING THE PROCEDURE, OR PATIENT VASCULAR CHARACTERISTICS. THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT. THIS IS 1 OF 2 MDR REPORTS SUBMITTED FOR THIS COMPLAINT, WITH ASSOCIATED REPORT NUMBERS OF 3008264254-2016-00069 AND 2954740-2016-00244.

    Description of Event or Problem · 1

    AS REPORTED VIA (B)(6), DURING ACUTE THROMBECTOMY AT THE HORIZONTAL PORTION OF THE MIDDLE CEREBRAL ARTERY (M1), PATIENT (B)(6) EXPERIENCED VASCULAR DAMAGE AND SUBARACHNOID HEMORRHAGE DURING THE INDEX PROCEDURE. BEFORE THE PROCEDURE, THE NIHSS WAS 25. THE PHYSICIAN HAD PASSED THE COMPLAINT REVIVE SE (FRS21452299/T10106) USING A PROWLER SELECT PLUS MICROCATHETER (CATALOG/LOT UNK), FOR OCCLUSION OF THE BLOOD VESSEL LESION (M1) TWICE, HOWEVER, THE OCCLUSION WAS NOT RECANALIZED. BEFORE THE THIRD PASS, THE MICROCATHETER WAS ADVANCED TO NEAR THE OCCLUSION SITE AND ANGIOGRAPHY WAS PERFORMED. IT WAS CONFIRMED THAT PART OF M1 WAS RECANALIZED, AND THERE WAS LEAKAGE OF CONTRAST MEDIA OUTSIDE THE BLOOD VESSEL. IT WAS UNCLEAR IF THE CAUSE OF THE BLEEDING WAS DISSECTION OR PERFORATION. A BALLOON CATHETER WAS INFLATED, AND PROTAMINE WAS ADMINISTERED INTRAVENOUSLY. THE PHYSICIAN WAS UNEASY ABOUT THE BLEEDING CONTINUING BY THE COLLATERAL CIRCULATION FROM THE ANTERIOR COMMUNICATING ARTERY, AND THE MICROCATHETER WAS REMOVED. THE PATIENT WAS FOLLOWED FOR ABOUT 30 MINUTES. THEN RE-OCCLUSION WAS CONFIRMED AT M1, AND THE BLEEDING STOPPED NATURALLY. THE PROCEDURE WAS COMPLETED. DURING THE PROCEDURE SUBARACHNOID HEMORRHAGE DEVELOPED. IT WAS REPORTED THAT THE HEMORRHAGE CAUSED ¿VITAL CHANGE¿ BUT THE NEUROLOGICAL EFFECT WAS UNCLEAR. FORTUNATELY THE BLEEDING WAS SLIGHT, AND THE NEXT DAY THE NIHSS WAS 20, AND 7 DAYS AFTER THE PROCEDURE, NIHSS WAS 21. IT WAS UNKNOWN IF THE VASCULAR DAMAGE OCCURRED DURING THE REVIVE SE SECOND PASS OR PUNCTURE WITH THE MICROWIRE WHEN ADVANCING THE MICROCATHETER FOR THE THIRD REVIVE SE PASS. IT WAS REPORTED THAT THE VASCULAR DAMAGE MAY HAVE BEEN CAUSED BY THE REVIVE SE OR THE PROCEDURE. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO OR AFTER THE EVENT. THE PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. NO FURTHER INFORMATION WAS AVAILABLE, INCLUDING OTHER DEVICES USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687922 REVIVE - THROMBECTOMY DEVICE EMBOLECTOMY CATHETER DXE MEDOS INTERNATIONAL SARL NA T10106

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L UNSPECIFIED PROWLER SELECT PLUS