BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LVIS HDE

    MDR report key: 23307975 · Received October 16, 2025

    Report

    Report Number
    2032493-2025-90573
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    October 25, 2016
    Report Date
    October 16, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    QCA
    UDI-DI
    00812636022192
    PMA / PMN Number
    H130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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. 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. 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.

    Description of Event or Problem · 0

    AS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY: EVENT SUMMARY: FIVE DAYS AFTER THE INDEX PROCEDURE, MRI BRAIN REVEALED SIGNS OF LEFT CEREBRAL PEDUNCLE STROKE. THERE IS AN INTRAPARENCHYMAL HEMATOMA IN THE RIGHT FRONTAL LOBE; THIS IS UNCHANGED FROM THE RECENT CT EXAMINATION. PNEUMOCEPHALUS WITH AIR BUBBLES IN BOTH LATERAL VENTRICLES IS PRESENT. BASED ON NEUROSURGERY CONSULT, MRI FINDINGS WERE FOUND AS NOT ACUTELY CONCERNING, AND REQUIRED NO CHANGE IN MANAGEMENT. PATIENT REMAINS SEDATED, INTUBATED AND MECHANICALLY VENTILATED. ADDITIONALLY, WITH NO EVIDENCE OF VASOSPASM ON DAILY TRANS CRANIAL DOPPLERS AND CEREBRAL ANGIOGRAM, WAS GIVEN THE OKAY TO BEGIN NORMALIZING BP, AND BEGIN SPONTANEOUS BREATHING TRIALS FOR EXTUBATING. REPEAT MRI, NINE DAYS AFTER THE INDEX PROCEDURE, DEMONSTRATED MULTIPLE SMALL EMBOLIC CVAS. EVENT WAS RESOLVED WITHOUT SEQUELAE. THE EVENT WAS ADJUDICATED AS STUDY DEVICE-RELATED, DISEASE-RELATED AND MEDICATION-RELATED. INDEX PROCEDURE: PATIENT PRESENTED TO ED WITH SAH AND BASILAR ARTERY ANEURYSM, UNDERWENT CEREBRAL ANGIOGRAM WITH STENTING OF BASILAR ARTERY BIFURCATION, COIL EMBOLIZATION OF BASILAR ARTERY ANEURYSM, AND PLACEMENT OF EVD. PATIENT DID SHOW SOME IMPROVEMENT. POST-PROCEDURE, PATIENT WAS EXTUBATED. HOWEVER, PROGRESSIVELY, PATIENT'S MENTAL STATUS STARTED DETERIORATING, AND THE PATIENT DID NOT HAVE ANY ABILITY TO PROTECT THE AIRWAY. PATIENT ALSO HAD INCREASED SECRETIONS. FOUR DAYS AFTER THE INDEX PROCEDURE, PATIENT WAS RE-INTUBATED AND PLACED ON MECHANICAL VENTILATION. PATIENT WAS ALSO SUSPECTED TO HAVE VASOSPASM. PLACED ON 3% SALINE. VASOPRESSORS WERE USED TO TARGET PATIENT'S MEAN ARTERIAL PRESSURE GREATER THAN OR EQUAL TO 70. PROGRESSIVELY, THE PATIENT DID SHOW SOME IMPROVEMENT IN NEUROLOGIC STATUS. THERE WAS INTERMITTENT FOLLOWING OF COMMAND, BUT THIS WAS NOT CONSISTENT. ALSO, PATIENT DID HAVE SECRETIONS. UNABLE TO EXTUBATE HER. FIFTEEN DAYS AFTER THE PROCEDURE, PATIENT HAD SEIZURE-LIKE ACTIVITY AND RECEIVED FOSPHENYTOIN. PATIENT WAS IN STATUS EPILEPTICUS SINCE THE MORNING. PATIENT REQUIRED MULTIPLE DOSAGES OF BENZODIAZEPINES, WAS STARTED ON PROPOFOL DRIP AND ALSO REQUIRED A DOSE OF PARALYTIC. THE PATIENT WENT INTO A PEA CARDIAC ARREST DUE TO SEVERE ENCEPHALOPATHY FROM THE STATUS EPILEPTICUS. CPR WAS DONE BY THE CODE TEAM FOR A TOTAL OF SIXTEEN MINUTES, FOLLOWING WHICH PATIENT HAD RETURN OF SPONTANEOUS CIRCULATION. THE NEXT DAY, PATIENT'S OVERALL PROGNOSIS WAS CONSIDERED TO BE RATHER POOR FROM THE NEUROLOGIC STANDPOINT. PATIENT PASSED AWAY AFTER WITHDRAWAL OF CARE AND INITIATION OF COMFORT CARES, PER FAMILY DIRECTIVE. THE SEIZURE-LIKE ACTIVITY AND DEATH WERE NOT ADJUDICATED TO BE STUDY DEVICE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2392102 LVIS HDE INTRACRANIAL NEUROVASCULAR STENT QCA MICROVENTION, INC. 212525-LVIS 16070124 00812636022192

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other