BEUDAMED
    FDA Adverse Event Death Summary report: N

    LVIS D

    MDR report key: 23267043 · Received October 10, 2025

    Report

    Report Number
    2032493-2025-90553
    Event Type
    Death
    Date Received
    October 10, 2025
    Date of Event
    August 22, 2023
    Report Date
    October 10, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    QCA
    PMA / PMN Number
    P170013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE PHYSICAL DEVICE WAS NOT AVAILABLE FOR EVALUATION TO INVESTIGATE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. SUPPLEMENTAL IMAGING WAS ALSO UNAVAILABLE FOR REVIEW; WITHOUT IMAGING, THE INVESTIGATION CANNOT VERIFY THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION FURTHER EXAMINE THE CAUSE OF THE REPORTED EVENT. THIS INFORMATION MAY BE UPDATED IF ADDITIONAL INFORMATION IS PROVIDED AT A LATER DATE. A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY, THE PATIENT PRESENTED WITH LEFT-SIDED WEAKNESS AND WAS FOUND TO HAVE RECURRENT BASILAR APEX ANEURYSM. PATIENT HAD INDEX PROCEDURE OF RIGHT PCA WITH AN INTRALUMINAL SUPPORT STENT PLACEMENT AND BASILAR ARTERY ANEURYSM COIL EMBOLIZATION PERFORMED. REPORTEDLY, ON (B)(6)2023, 15 DAYS POST PROCEDURE, THE PATIENT UNDERWENT SURGICAL RE-TREATMENT OF TARGET ANEURYSM USING A FLOW DIVERTER PIPELINE EMBOLIZATION DEVICE. THE PATIENT WAS EXTUBATED ON (B)(6)2023 AND WAS PENDING TRANSFER TO 4N PER PRIMARY TEAM. THE PATIENT WAS NOTED TO BE DECEASED AND EXITED THE STUDY (B)(6)2024 DUE TO DEATH FROM UNKNOWN CAUSE. THE SITE DOES NOT HAVE ANY INFORMATION REGARDING THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328389 LVIS D INTRACRANIAL COIL-ASSIST STENT QCA MICROVENTION, INC. 212922-LVIS-D-PMA 0000227089

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death COVIDIEN PIPELINE FLEX (MEDTRONIC).