BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRED 27

    MDR report key: 12586924 · Received October 6, 2021

    Report

    Report Number
    2032493-2021-00401
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    September 8, 2021
    Report Date
    September 8, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OUT
    PMA / PMN Number
    P180027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THE REPORTED PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND NOT AVAILABLE FOR ANALYSIS; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC. WILL ISSUE A SUPPLEMENTAL MDR REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES THROMBUS AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FRED FLOW DIVERTER STENT AND HYDROSOFT3D EMBOLIZATION COILS WERE USED TO TREAT AN INTERNAL CAROTID ARTERY ANEURYSM (ICA). BOTH THE STENT AND COIL WERE SUCCESSFULLY DEPLOYED AND POSITIONED, AND ANGIOGRAPHY SHOWED NO ISSUES. ANGIOGRAPHY WAS THEN PERFORMED AGAIN BUT THE INSIDE AND DISTAL PART OF THE FRED WERE NOT VISIBLE AND IN-STENT THROMBOSIS WAS SUSPECTED. 200MG OF EFFIENT WAS ADMINISTERED BEFORE PTA WITH A BALLOON WAS PERFORMED. SOME STENOSIS REMAINED, BUT RECANALIZATION WAS ACHIEVED. PATIENT HAD NO NEUROLOGICAL SYMPTOMS OBSERVED AND WAS DISCHARGED. THE PHYSICIAN COMMENTED THAT THE SUDDEN THROMBOSIS MIGHT HAVE BEEN CAUSED BY THE HYDROSOFT 3D COIL, WHICH THE PHYSICIAN DOES NOT USUALLY USE AND THE CLOTS IN THE ANEURYSM MIGHT BE PUSHED OUT BY COIL. REPORTEDLY, THE PATIENT HAD BEEN TAKING ASPIRIN 100MG AND CLOPIDOGREL 75MG 8 DAYS BEFORE THE PROCEDURE. TEG WAS PERFORMED AS A PREOPERATIVE PLATELET COAGULATION TEST, AND THE RESULTS WERE MA-ADP45.3 AND MA-AA20.9 THIS IS REPORT 1 OF 2 (REF: MFR. REPORT# 2032493-2021-00402).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482791 FRED 27 FLOW DIVERTER OUT MICROVENTION, INC. MV-F451827 20102856V

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention