BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRED

    MDR report key: 14220246 · Received April 27, 2022

    Report

    Report Number
    2032493-2022-00165
    Event Type
    Death
    Date Received
    April 27, 2022
    Report Date
    March 28, 2022
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OUT
    PMA / PMN Number
    P180027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A SEARCH FOR PRODUCTION-RELATED NCRS COULD NOT BE PERFORMED. THE DEVICE WAS IMPLANTED IN THE PATIENT AND WAS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR ANALYSIS. MEDICAL IMAGING WAS NOT AVAILABLE. THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES RUPTURE OR PERFORATION OF THE ANEURYSM AND DEATH AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE. CHOI, JAI HO, ET AL. "A SINGLE FLOW RE-DIRECTION ENDOLUMINAL DEVICE FOR THE TREATMENT OF LARGE AND GIANT ANTERIOR CIRCULATION INTRACRANIAL ANEURYSMS." (B)(6) MEDICAL JOURNAL 63.4 (2022): 349.

    Description of Event or Problem · 0

    AS REPORTED THROUGH THE ARTICLE TITLED, "A SINGLE FLOW RE-DIRECTION ENDOLUMINAL DEVICE FOR THE TREATMENT OF LARGE AND GIANT ANTERIOR CIRCULATION INTRACRANIAL ANEURYSMS" PUBLISHED IN (B)(6)MEDICAL JOURNAL, THE COMPANY BECAME AWARE OF A PATIENT THAT WAS TREATED WITH A FRED STENT FOR AN UNRUPTURED ANEURYSM OF THE INTERNAL CAROTID ARTERY BETWEEN (B)(6) 2018 AND (B)(6) 2020. THE PATIENT EXPERIENCED A RUPTURE ON POSTOPERATIVE DAY 275, THE CAUSE OF WHICH IS UNKNOWN, AND ULTIMATELY PASSED AWAY. THIS PUBLISHED STUDY REPORTED ON PROCEDURE-RELATED COMPLICATIONS AND RISK FACTORS ASSOCIATED WITH TREATMENT OF LARGE AND GIANT ANEURYSMS WITH THE FRED DEVICE. THE ARTICLE DID NOT IDENTIFY THE FRED DEVICE INVOLVED IN THIS LATE-PERIOD COMPLICATION, THE DEVICE WAS NOT RETURNED, AND NO MEDICAL IMAGING WAS AVAILABLE. THERE IS NO INDICATION THAT THE FRED DEVICE HAD ANY NON-CONFORMANCE. THE COMPANY NOTES, HOWEVER, THAT THE FRED INSTRUCTIONS FOR USE (IFU) IDENTIFIES RUPTURE OR PERFORATION OF THE ANEURYSM AND DEATH AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096459 FRED FLOW DIVERTER OUT MICROVENTION, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death