BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LVIS HDE

    MDR report key: 24679277 · Received March 24, 2026

    Report

    Report Number
    2032493-2026-00188
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    December 15, 2017
    Report Date
    March 24, 2026
    Manufacturer
    MICROVENTION, INC.
    Product Code
    QCA
    PMA / PMN Number
    H130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE LOT NUMBER WAS NOT PROVIDED, A SEARCH FOR PRODUCTION-RELATED NON-CONFORMANCES COULD NOT BE PERFORMED. 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. A DETAILED MEDICAL REVIEW OF THE PROVIDED PROCEDURE NOTE REVEALED THAT ON POST-OPERATIVE DAY 98, RESIDUAL ANEURYSM WAS TREATED WITH SURGICAL PROCEDURE OF A SECOND LVIS PLACED IN INDEX LVIS WITH THE OUTCOME OF RESOLVED WITHOUT SEQUELAE. DATA REVIEWED INDICATES THAT MALFUNCTION OCCURRED WITH THE LVIS DEPLOYED. RUNOFF WAS PERFORMED AFTER FULL DEPLOYMENT OF THE LVIS 3.5 MM X 22 MM STENT, SHOWING GOOD POSITIONING WITH SUBOPTIMAL WALL APPOSITION. MULTIPLE ANGIOPLASTIES WERE PERFORMED AND SERIAL-RADIOGRAPHS IMAGES CONFIRMED GOOD WALL APPOSITION OF THE NEWLY PLACED LVIS STENT. BASED ON THE REVIEW OF THE AVAILABLE DATA, A DEVICE MALFUNCTION WAS REPORTED FOR THE LVIS DEVICE AND THE RELATIONSHIP OF THE EVENT TO THE LVIS DEVICE CANNOT BE RULED OUT. HOWEVER, WITHOUT THE RETURN AND PHYSICAL EVALUATION OF THE DEVICE, THE INVESTIGATION CANNOT FURTHER EXAMINE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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: RESIDUAL ANEURYSM. SITE REPORTED EVENT OF RESIDUAL ANEURYSM WITH ONSET NINETY-EIGHT (98) DAYS AFTER INDEX PROCEDURE, NON-SERIOUS, GRADE 1. DIAGNOSTIC CEREBRAL ANGIOGRAM SHOWED 2.2 MM RESIDUAL FILLING OF THE NECK OF THE LEFT ICA ANEURYSM. RESIDUAL ANEURYSM WAS TREATED WITH SUCCESSFUL LVIS STENT PLACEMENT INTO THE LEFT INTERNAL CAROTID ARTERY WITHIN THE PREVIOUSLY PLACED LVIS STENT IN A TELESCOPING FASHION. OUTCOME WAS RESOLVED WITHOUT SEQUELAE. DURING THE SAME PROCEDURE, THERE WAS NOTED A MALFUNCTION OF THE LVIS DEPLOYED. A RUNOFF WAS PERFORMED AFTER FULL DEPLOYMENT OF THE LVIS 3.5 MM X 22 MM STENT. THIS SHOWED GOOD POSITIONING OF THE STENT WITH SUBOPTIMAL WALL APPOSITION. NEXT, A 4 MM X 10 MM BALLOON CATHETER AND MICROWIRE WERE ADVANCED. MULTIPLE ANGIOPLASTIES WERE PERFORMED IN A DISTAL TO PROXIMAL FASHION. SERIAL SPOT X-RAY IMAGES AND CONTRAST RUN OFF WERE PERFORMED. THESE CONFIRMED GOOD WALL APPOSITION OF THE NEWLY PLACED LVIS STENT. INDEX PROCEDURE WAS STENT ASSISTED COIL EMBOLIZATION OF THE LEFT ICA ANEURYSM. THE EVENT WAS ADJUDICATED AS DEVICE-RELATED AND PROCEDURE-RELATED. CTA DONE LATER, TWO YEARS AND NINE MONTHS AFTER TREATMENT OF RESIDUAL ANEURYSM, SHOWED 100% ANEURYSM ANGIOGRAPHIC OCCLUSION, RAYMOND ROY 1, NO STENT MIGRATION AND 0% IN-STENT STENOSIS. SUBJECT EXITED THE STUDY THREE MONTHS AFTER CTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741171 LVIS HDE INTRACRANIAL COIL-ASSIST STENT QCA MICROVENTION, INC. 212525-LVIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention