BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LVIS HDE

    MDR report key: 22401325 · Received July 3, 2025

    Report

    Report Number
    2032493-2025-90300
    Event Type
    Injury
    Date Received
    July 3, 2025
    Date of Event
    October 23, 2019
    Report Date
    July 3, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    QCA
    UDI-DI
    00812636022192
    PMA / PMN Number
    H130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE PRODUCT CODE IS 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. 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: SUBJECT WITH RECURRENT GIANT RIGHT ANTERIOR CEREBRAL A2 SEGMENT ANEURYSM TREATED ON WITH ELECTIVE INDEX PROCEDURE OF SUCCESSFUL STENT ASSISTED COIL EMBOLIZATION. DID WELL OVERNIGHT AND WAS DISCHARGED HOME. SUBSEQUENT FOLLOW UP MRA ON EVENT DATE, 645 DAYS POST-OP INDEX PROCEDURE, SHOWED PROGRESSIVE INCREASE IN THE SIZE AND PERSISTENT FILLING OF GIANT RIGHT ANTERIOR CEREBRAL ARTERY A1-2 JUNCTION ANEURYSM. DIAGNOSED WITH PROGRESSIVE INCREASE IN THE SIZE OF RECANALIZED TARGET ANEURYSM WHICH IS CAUSED BY COMPACTION OF THE PREVIOUSLY PLACED COIL MASS, THE PREVIOUSLY PLACED LVIS STENT WAS PATENT. HE DOES NOT COMPLAIN OF ANY SYMPTOMS. HE UNDERWENT ENDOVASCULAR RETREATMENT OF THE TARGET ANEURYSM WITH IR INTRACRANIAL STENT, 9 MONTHS AFTER THE MRA. OUTCOME WAS RESOLVED WITHOUT SEQUELAE. EVENT WAS NOT A TRANSIENT ISCHEMIC ATTACK (TIA) OR STROKE. THERE WAS NO TARGET ANEURYSM REBLEED. THE LOCATION WAS IPSILATERAL TO TARGET LESION. EVENT WAS ADJUDICATED AS RELATED TO THE STUDY DEVICE, STUDY PROCEDURE, AND DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052330 LVIS HDE INTRACRANIAL COIL-ASSIST STENT QCA MICROVENTION, INC. 212525-LVIS 170504161 00812636022192

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention