BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRED X27

    MDR report key: 13026792 · Received December 17, 2021

    Report

    Report Number
    2032493-2021-00493
    Event Type
    Death
    Date Received
    December 17, 2021
    Date of Event
    October 24, 2021
    Report Date
    November 17, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OUT
    UDI-DI
    00842429107355
    PMA / PMN Number
    P180027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6, H10 (PROCEDURE IMAGES REVIEW). INTRA-OPERATIVE IMAGES WERE PROVIDED; HOWEVER, THE ACTUAL THROMBOSED STENT IS NOT IMAGED. THE PATIENT WAS LIKELY PREDISPOSED TO THROMBOSIS GIVEN THE HYPERTHROMBOGENICITY ASSOCIATED WITH THE ACUTE SAH AND THE SMALL CALIBER OF THE ARTERY WHERE THE FRED WAS DEPLOYED. THE PHYSICAL DEVICE WAS NOT AVAILABLE FOR ANALYSIS; THEREFORE, THE INVESTIGATION COULD NOT DETERMINE IF A CONDITION EXISTED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    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 WAS IMPLANTED IN THE PATIENT AND NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. HOWEVER, PROCEDURE IMAGES WERE PROVIDED AND ARE BEING REVIEWED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES DEATH AND HEMORRHAGE, INCLUDING INTRACRANIAL HEMORRHAGE (ICH), SUBARACHNOID HEMORRHAGE (SAH) AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT CAME INTO THE HOSPITAL WITH AN ACUTE, SIGNIFICANT BLEED OF A RIGHT POSTERIOR INFERIOR CEREBELLA ARTERY (PICA) ANEURYSM. THE PATIENT WAS IN CRITICAL CONDITION, BUT TREATMENT WAS ATTEMPTED BY PLACEMENT OF A FRED X STENT IN FRONT OF THE ANEURYSM. AFTER PLACING THE FRED X, A THROMBUS FORMED THAT WAS NOT RESOLVED, AS THE PATIENT HAD ALREADY SUFFERED SERIOUS INJURY FROM THE ACUTE BLEED. AFTER THE CLOSURE, THE PATIENT SUFFERED AN ADDITIONAL STROKE AND DIED ON THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925605 FRED X27 FLOW DIVERTER OUT MICROVENTION, INC. XFRED2508-MVE 20121011VM 00842429107355

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death