BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LVIS JR.

    MDR report key: 22918915 · Received August 28, 2025

    Report

    Report Number
    2032493-2025-90440
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 3, 2025
    Report Date
    October 17, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    QCA
    UDI-DI
    00842429103302
    PMA / PMN Number
    H130005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOUND THE STENT RETURNED DEFORMED AT THE PROXIMAL END, WHICH IS CONSISTENT WITH THE INABILITY TO OPEN IN VITRO AS DESCRIBED IN THE REPORTED EVENT; FURTHERMORE, THE STENT DEFORMITY WOULD HAVE CONTRIBUTED TO THE ALLEGED ADVANCEMENT DIFFICULTY IF THE CONDITION WAS PRESENT AT THE TIME OF THE DEPLOYMENT ATTEMPT IN VIVO. AFTER THE STENT SHAPE WAS RESTORED DURING THE INVESTIGATION, THE STENT WAS ABLE TO ADVANCE THROUGH AN IN-HOUSE MICROCATHETER WITHOUT RESISTANCE. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE EXACT CONDITIONS OR CIRCUMSTANCES THAT LED TO THE PROXIMAL STENT DEFORMITY, BUT THIS CONDITION IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES EXCEEDING ITS YIELD STRENGTH. THE MICROCATHETER USED IN THE PROCEDURE WAS NOT RETURNED FOR EVALUATION, SO THE INVESTIGATION COULD NOT DETERMINE IF IT HAD CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. 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.

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS STATED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RETURNED DESPITE A DEVICE RETURN ATTEMPT. ONGOING ATTEMPTS WILL BE MADE FOR THE DEVICE RETURN. THE ALLEGED PRODUCT ISSUE/EVENT AS DESCRIBED COULD NOT BE CONFIRMED. IF THE DEVICE IS RECEIVED AT A LATER DATE, AN INVESTIGATION WILL BE PERFORMED AND 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT.

    Description of Event or Problem · 0

    AS REPORTED: DURING THE STENT-ASSISTED EMBOLIZATION OF A MIDDLE CEREBRAL ARTERY ANEURYSM, AFTER THE MICROCATHETER WAS POSITIONED, THE STENT WAS DELIVERED THROUGH THE PROTECTIVE SHEATH INTO THE MICROCATHETER ACCORDING TO THE NORMAL PROCEDURE. HOWEVER, WHEN THE STENT WAS DEPLOYED TO THE HALFWAY POSITION, IT COULD NOT BE PUSHED FURTHER. DESPITE TWO REPEATED ATTEMPTS, THE STENT REMAINED IMMOVABLE. IT WAS WITHDRAWN ENTIRELY, AND AN IN VITRO EXAMINATION REVEALED THAT THE STENT FAILED TO OPEN AND HAD SEPARATED. REGARDING THE REMOVAL OF THE FIRST STENT, THE STENT TOGETHER WITH THE MICROCATHETER AS A WHOLE WAS RETRACTED INTO THE INTERMEDIATE CATHETER, THEN REMOVED. AFTER THE COMPLETE WITHDRAWAL, THE MICROCATHETER WAS REPOSITIONED, AND A NEW 2.5×17 STENT WAS REPLACED. THE FIRST HALF OF ITS DEPLOYMENT PROCEEDED NORMALLY, AND ANGIOGRAPHY SHOWED EXCELLENT DEPLOYMENT RESULTS. THE STENT WAS THEN FULLY DEPLOYED, AND ANOTHER ANGIOGRAPHY CONFIRMED SATISFACTORY OUTCOMES. THE SURGERY WAS COMPLETED USING 4 COILS AND 1 STENT. PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248068 LVIS JR. INTRACRANIAL NEUROVASCULAR STENT QCA MICROVENTION, INC. 172014-CASJ-C 0000645887 00842429103302

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HEADWAY 17 MICROCATHETER