BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LVIS HDE

    MDR report key: 22066997 · Received May 21, 2025

    Report

    Report Number
    2032493-2025-90174
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    August 1, 2018
    Report Date
    May 21, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    QCA
    UDI-DI
    00812636022239
    PMA / PMN Number
    H130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: THE PRODUCT CODE IN SECTION D SHOULD BE "NJE", HOWEVER, THAT IS NOT AN AVAILABLE OPTION. THUS, "QCA" WAS CHOSEN AS IT WAS THE CLOSEST MATCH. 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: TARGET ANEURYSM RUPTURE AND RETREATMENT: LEFT CAROTID CAVERNOUS FISTULA FROM LEFT INFERIOR PETROSAL SINUS WITH COMPLETE OBLITERATION OF THE LEFT CAVERNOUS ICA ANEURYSM, VISIT TO THE EMERGENCY ROOM COMPLAINING OF THE WORST HEADACHE OF HER LIFE. TARGET CAVERNOUS ANEURYSM TREATED WITH STENT ONLY, GOES ON TO RUPTURE WITH DEVELOPMENT OF CCF AND UNDERGOES TRANSVENOUS TREATMENT. THE SEVERITY OF THE EVENT WAS A GRADE 3. ADVERSE EVENT NOT ASSOCIATED WITH A NEUROLOGICAL DEFICIT. THE EVENT LOCATION WAS IPSILATERAL TO TARGET LESION. THE EVENT WAS NOT A TRANSIENT ISCHEMIC ATTACH (TIA) OR STROKE, TARGET ANEURYSM REBLED. THE INDEX PROCEDURE WAS PERFORMED SEVEN AND A HALF MONTHS PRIOR. THE EVENT WAS RESOLVED WITHOUT SEQUELAE. THE EVENT WAS ADJUDICATED TO BE RELATED TO THE STUDY DEVICE, STUDY PROCEDURE, AND DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367823 LVIS HDE INTRACRANIAL NEUROVASCULAR STENT QCA MICROVENTION, INC. 214035-LVIS-D-HDE 17061654U 00812636022239

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention