BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LVIS HDE

    MDR report key: 22880019 · Received August 22, 2025

    Report

    Report Number
    2032493-2025-90429
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    July 18, 2017
    Report Date
    August 26, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    QCA
    PMA / PMN Number
    H130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE LOT NUMBER WAS NOT PROVIDED, A SEARCH FOR PRODUCTION-RELATED NCRS COULD NOT BE PERFORMED. THE DEVICE WAS IMPLANTED AND THEREFORE NOT AVAILABLE FOR RETURN AND INVESTIGATION BY THE MANUFACTURER. THE INVESTIGATION IS ONGOING AND UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR WILL BE SUBMITTED. 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. 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.

    Additional Manufacturer Narrative · 0

    MEDICAL REVIEW OF THE PROVIDED OPERATIVE NOTE INDICATES THAT THERE WAS MIGRATION OF THE PROXIMAL ASPECT OF THE LVIS STENT DURING THE PERFORMANCE OF STENT-COIL EMBOLIZATION OF AN ANEURYSM IN THE RIGHT POSTERIOR COMMUNICATING ARTERY. DATA REVIEWED INDICATES THAT ANOTHER LVIS WAS DEPLOYED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO IMMEDIATE COMPLICATIONS, AND THE PATIENT WAS DISCHARGED TO THE ICU IN GOOD CONDITION. BASED ON THE REVIEW OF THE AVAILABLE OPERATIVE NOTE DATA, THE RELATIONSHIP OF THE EVENT TO THE DEVICE CANNOT BE RULED OUT; HOWEVER, THE DATA DOES NOT EXPLAIN WHY THE MIGRATION OCCURRED. NO DEVICE MALFUNCTION WAS REPORTED AS ASSOCIATED WITH THE REPORTED DEVICE MIGRATION AND/OR NO DEVICE MALFUNCTION WAS REPORTED AS THE CAUSE OF THE REPORTED DEVICE MIGRATION. WITHOUT THE RETURN AND PHYSICAL EVALUATION OF THE DEVICE, THE INVESTIGATION COULD NOT DETERMINE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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. 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: DURING INDEX PROCEDURE TO TREAT AN UNRUPTURED 4 MM WIDE NECKED RIGHT POSTERIOR COMMUNICATING ANEURYSM, THERE WAS MIGRATION OF THE PROXIMAL ASPECT OF THE FIRST LVIS. SUCCESSFUL LVIS STENT-ASSISTED COIL EMBOLIZATION WAS COMPLETED WITH SECOND LVIS DEVICE. AS REPORTED THROUGH THE OP NOTE: AN LVIS 4.5MM X 18MM STENT SYSTEM WAS ADVANCED AND INITIALLY DEPLOYED INTO THE M1 SEGMENT AND PULLED BACK INTO THE SUPRACLINOID ICA. BECAUSE OF MORE PROXIMAL POSITIONING THAN OPTIMUM, THE DEVICE WAS RE-SHEATHED AND THEN REPOSITIONED AND DEPLOYED WITH THE DISTAL STRUTS OPTIMALLY POSITIONED AT THE ICA TERMINUS. ONCE THE STENT WAS HALFWAY DEPLOYED AND THE STRUTS OF THE STENT ACROSS THE OSTIUM OF THE ANEURYSM, WE ATTEMPTED TO NAVIGATE THE SECOND MICROCATHETER INTO THE ANEURYSM BUT AGAIN NO STABLE POSITIONING COULD BE ACHIEVED. NEXT, THE STENT WAS FULLY DEPLOYED AND WE AGAIN TRY TO CATHETERIZE THE ANEURYSM TO NO AVAIL. THE MICROCATHETER 0.021" WAS REMOVED AND THE MICROCATHETER WAS PULLED BACK INTO THE CAVERNOUS SEGMENT AND USED TO SELECT THE ANEURYSM THROUGH THE INTERSTICES OF THE STENT. AT THIS POINT, IT WAS NOTED THAT DURING COILING, THE PROXIMAL ASPECT OF THE STENT HAD MIGRATED INTO THE ANEURYSM. ALL SYSTEMS WERE REMOVED AND A NEW MICROCATHETER 0.017" WAS USED WITH A GUIDEWIRE AND WE SELECTED THE LUMEN OF THE STENT ACROSS THE OUTER ASPECT OF THE PROXIMAL STENT AND WERE ABLE TO NAVIGATE INTO THE TRUE LUMEN TO SELECT THE A FRONTAL OPERCULAR M2 SEGMENT. ONCE WE WERE IN AN M2 SEGMENTS, THE MICROCATHETER 0.017" WAS EXCHANGED FOR A MICROCATHETER 0.021" OVER AN EXCHANGE WIRE. NEXT, ANOTHER LVIS 4.5 MM X 22 MM STENT WAS HALFWAY DEPLOYED AND DRAGGED BACK SO THAT THE DISTAL STRUTS MATCHED BACK OF THE FIRST OF THE LVIS. THEN, THE ENTIRETY OF THE STENT WAS DEPLOYED WITH THE PROXIMAL ASPECT OF THE STRUTS RIGHT AT THE SIPHON. IN ORDER TO MAINTAIN THE TRUE LUMEN, WE RECAPTURED MUCH OF THE DELIVERY SYSTEM WITH THE MICROCATHETER 0.021" REMAINING WITHIN THE TRUE LUMEN OF THE STENT. AS DESCRIBED ABOVE, MIGRATION OF THE STENT OCCURRED DURING DEPLOYMENT OF THE FIRST COIL ATTEMPTS. FOLLOWING SELECTION OF THE INTRALUMINAL SPACE ACROSS THE INFERIOR MARGIN OF THE STENT AND DEPLOYMENT OF THE SECOND STENT, IT APPEARS TO BRIDGE THE NECK OF THE ANEURYSM WELL. THERE WERE NO IMMEDIATE COMPLICATIONS. THE PATIENT WAS DISCHARGED TO THE ICU IN GOOD CONDITION, NEUROLOGICALLY UNCHANGED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263452 LVIS HDE INTRACRANIAL COIL-ASSIST STENT QCA MICROVENTION, INC. 213015-LVIS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention HEADWAY 17 MICROCATHETER.| HEADWAY 21 MICROCATHETER.| SYNCHRO 2 SOFT MICRO GUIDEWIRE.| TRANSEND 14 EXCHANGE WIRE.