BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 6182938 · Received December 16, 2016

    Report

    Report Number
    2954740-2016-00320
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Report Date
    November 25, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DXE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS 1 OF 1 INITIAL REPORT FOR THIS COMPLAINT ASSOCIATED WITH MFR #2954740-2016-00320. (B)(4). (B)(6). THE ROOT CAUSE OF THE REPORTED PRODUCT ISSUE CANNOT BE DETERMINED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED BECAUSE THE LOT FOR THE PRODUCT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A REVIVE SE ((B)(4)) WAS USED DURING A CAS OF A STENOSIS IN THE INTERNAL CAROTID ARTERY PROCEDURE, ON AN UNKNOWN DATE, WHERE DIFFICULTY WAS EXPERIENCED IN RETRACTING THE DEVICE POST STENT DEPLOYMENT. A GUIDING CATHETER (NO INFO) WAS DELIVERED TO THE COMMON CAROTID ARTERY TO PERFORM CAS. THEN A MICROCATHETER (NO INFO) WAS ADVANCED TO THE LESION AND THE REVIVE SE (COMPLAINT PRODUCT) WAS DEPLOYED. WHEN THE REVIVE SE WAS RETRACTED BACK INTO THE GUIDING CATHETER, IT CAUGHT A STENT THAT HAD BEEN PREVIOUSLY IMPLANTED IN THE CAROTID ARTERY AND COULD NOT BE RETRACTED. THEREFORE, THE GUIDING CATHETER THAT WAS IN THE COMMON CAROTID ARTERY LED TO THE INTERNAL CAROTID ARTERY AND SUCCESSFULLY RETRACTED THE REVIVE SE INTO THE GUIDING CATHETER. REPORTEDLY, THE PATIENT¿S INFORMATION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WERE ALSO UNKNOWN. NO REPORT OF THE OTHER DEVICES USED DURING THIS PROCEDURE IS AVAILABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY/COMPLICATION REPORTED. 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 AND AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICRO CATHETER. THE PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832524 REVIVE - THROMBECTOMY DEVICE EMBOLECTOMY CATHETER DXE MEDOS INTERNATIONAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1