BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LVIS HDE

    MDR report key: 24709031 · Received March 30, 2026

    Report

    Report Number
    2032493-2026-00193
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    January 28, 2020
    Report Date
    March 26, 2026
    Manufacturer
    MICROVENTION, INC.
    Product Code
    QCA
    UDI-DI
    00812636022239
    PMA / PMN Number
    H130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE PRODUCT CODE IN SECTION D SHOULD BE NJE, HOWEVER, THAT IS NOT AN AVAILABLE OPTION IN THE SYSTEM. THUS, THE PRODUCT CODE QCA WAS SELECTED AS IT IS A SIMILAR CODE. 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. THIS STUDY IS ONGOING AND DEVICE/PROCEDURE RELATEDNESS DETERMINATIONS CAN BE RE-ADJUDICATED BY INDEPENDENT REVIEWERS/PHYSICIANS. THE STUDY DEVICE AND STUDY PROCEDURE RELATEDNESS CAN CHANGE AS A RESULT OF THESE REVIEWS. MICROVENTION IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MICROVENTION, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MICROVENTION HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MICROVENTION, OR ITS EMPLOYEES THAT THE DEVICE, MICROVENTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT.

    Description of Event or Problem · 0

    AS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY: PATIENT BEGAN TO REPORT DIPLOPIA; FOUND TO HAVE 9 MM RECURRENCE OF ANEURYSM. PATIENT OUTCOME WAS RESOLVED WITH SEQUELAE. THE EVENT WAS ADJUDICATED AS RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE. INDEX PROCEDURE WAS PERFORMED TWO YEARS PRIOR. RECURRENT ANEURYSM WAS TREATED WITH SUCCESSFUL FLOW DIVERTER STENT-ASSISTED COIL EMBOLIZATION OF RECURRENT LEFT PCOM ANEURYSM THIRTY-SEVEN (37) DAYS AFTER REPORT OF DIPLOPIA. SITE DID NOT PROVIDE THE OPERATIVE REPORT. SITE DID NOT PROVIDE ANY PROGRESS NOTE. PATIENT HAD MRA TWO YEARS AFTER RETREATMENT, TARGET ANEURYSM WAS RAYMOND 3, 95% OCCLUSION, NO IN-STENT STENOSIS, NO STENT MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774952 LVIS HDE INTRACRANIAL COIL-ASSIST STENT QCA MICROVENTION, INC. 214035-LVIS 17070452C 00812636022239

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention