BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LVIS HDE

    MDR report key: 22900741 · Received August 26, 2025

    Report

    Report Number
    2032493-2025-90431
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    November 10, 2016
    Report Date
    December 19, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    QCA
    UDI-DI
    00812636022215
    PMA / PMN Number
    H130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER AND AN UPDATE TO THE MODEL NUMBER OF THE DEVICE WERE RECEIVED. SECTION D AND H HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED REGARDING THE DEVICE. AS THE LOT NUMBER WAS RECEIVED, THE CODES IN SECTION H: TYPE OF INVESTIGATION HAVE ALSO BEEN UPDATED. THE INVESTIGATION CONCLUSION IS THE SAME AS PREVIOUSLY REPORTED. 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 INCOMPLETE OPENING OF THE LVIS STENT OCCURRED PROXIMAL TO THE ANEURYSM, REQUIRING THE PERFORMANCE OF ADDITIONAL INTERVENTION. DATA REVIEWED INDICATES SUCCESSFUL PLACEMENT OF THE LVIS STENT WITH IMPROVED WALL APPOSITION IN THE CAVERNOUS SEGMENT OF THE STENT AFTER ANGIOPLASTY WITH NO EVIDENCE OF FILLING DEFECTS OR FLOW LIMITATION. BASED ON THE REVIEW OF THE DATA, THE RELATIONSHIP OF THE EVENT TO THE LVIS STENT CANNOT BE RULED OUT. HOWEVER, THE DATA REVIEWED DOES NOT INDICATE THE CIRCUMSTANCES AS TO WHY THE LVIS STENT ENCOUNTERED INCOMPLETE OPENING. 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

    NO ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT.

    Description of Event or Problem · 0

    AS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY: INCOMPLETE OPEN OF THE LVIS DEVICE PROXIMAL TO THE ANEURYSM. IT WAS TREATED WITH ANGIOPLASTY. AS REPORTED THROUGH THE OP NOTE: PATIENT IS FEMALE WHO WAS SEEN IN CLINIC FOR INCIDENTAL RIGHT INTERNAL CAROTID ARTERY ANEURYSM. SHE UNDERWENT A DIAGNOSTIC CEREBRAL ANGIOGRAM REVEALING MULTIPLE INTRACRANIAL ANEURYSMS. SHE RETURNED FOR A STENT-ASSISTED COILING EMBOLIZATION OF THE RIGHT CAROTID CAVE ANEURYSM. A DETACHABLE COIL WAS ADVANCED INTO THE ANEURYSM AND DETACHED. THE PROCESS WAS SUBSEQUENTLY REPEATED WITH TWO DIFFERENT COILS. AFTER PLACEMENT OF THE THIRD COIL, THERE WAS PARTIAL OBLITERATION OF THE ANEURYSM WITH FULL PATENCY OF FLOW TO THE PARENT VESSEL. AN LVIS INTRALUMINAL SUPPORT STENT WAS THEN INSERTED INTO THE MICROCATHETER. THE STENT WAS UNSHEATHED. THE CATHETER AND STENT WERE THEN RETRACTED AND POSITIONED ACROSS THE ANEURYSM NECK. THE STENT WAS THEN UNSHEATHED FURTHER BY PUSHING THE WIRE SLIGHTLY FORWARD AND MANIPULATING THE CATHETER TENSION TO ASSURE GOOD WALL APPOSITION. FINALLY THE STENT WAS COMPLETELY DEPLOYED AND THE MICROCATHETER WAS ADVANCED OVER THE STENT DELIVERY WIRE, BACK THROUGH THE STENT AND THE WIRE WAS RECAPTURED. AN ANGIOGRAM WAS PERFORMED. A CT WAS OBTAIN FOR BETTER VISUALIZATION OF THE STENT. NEXT, A SUPER COMPLIANT BALLOON CATHETER WAS ADVANCED FOR A MICROWIRE AND PLACED INTO THE RIGHT ICA. THE BALLOON WAS CAREFULLY ADVANCED INSIDE THE LVIS STENT WITH THE MICROWIRE ASSISTANCE AND AN ANGIOPLASTY WAS PERFORMED IN THE CAVERNOUS SEGMENT OF THE STENT, THE BALLOON WAS DEFLATED AND REMOVED. WE THEN DECIDED TO TERMINATE THE COIL EMBOLIZATION PROCEDURE. POST EMBOLIZATION ANGIOGRAPHY OF THE RIGHT INTERNAL CAROTID ARTERY WAS PERFORMED. THERE WERE NO IMMEDIATE COMPLICATIONS. THE PATIENT WAS SUBSEQUENTLY TRANSPORTED TO THE NEUROLOGICAL INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1867427 LVIS HDE INTRACRANIAL COIL-ASSIST STENT QCA MICROVENTION, INC. 213025-LVIS 16100536 00812636022215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention HEADWAY 21 MICROCATHETER