BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LVIS D

    MDR report key: 22800688 · Received August 13, 2025

    Report

    Report Number
    2032493-2025-90399
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 20, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    QCA
    UDI-DI
    00842429115954
    PMA / PMN Number
    H130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 IMPLANTED AND THEREFORE NOT AVAILABLE FOR RETURN AND INVESTIGATION BY THE MANUFACTURER. HOWEVER, IMAGING WAS PROVIDED. THE INVESTIGATION IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE PRODUCT CODE IS 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 SINGLE RADIOGRAPHIC IMAGE WAS PROVIDED FOR REVIEW. THE IMAGE IS LOW QUALITY AND BLURRY. IT IS A PICTURE OF A RADIOGRAPHIC MONITOR IN THE PROCEDURE ROOM, TAKEN WITH A CELL PHONE. IT IS A SINGLE-SHOT UNSUBTRACTED FLUOROSCOPY IMAGE. A LARGE COIL MASS CAN BE SEEN IN WHAT IS LIKELY A LARGE TO GIANT ANEURYSM. THIS IMAGE DOES NOT EXPLAIN WHY THE DELIVERY SYSTEM TIP SEPARATED AS DESCRIBED IN THE REPORTED EVENT. 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. THE PRODUCT CODE IS 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: THE PATIENT HAD A GIANT POSTERIOR COMMUNICATING ARTERY ANEURYSM. AFTER ANESTHESIA, ROUTINE INTRACRANIAL STENT-ASSISTED COIL EMBOLIZATION WAS PERFORMED. DURING THE PROCEDURE, COILS WERE FIRST USED FOR EMBOLIZATION, AND THE EMBOLIZATION EFFECT WAS SATISFACTORY. THE INTRACRANIAL STENT SYSTEM WAS THEN DEPLOYED; AFTER COMPLETE DEPLOYMENT, THE DELIVERY GUIDEWIRE WAS SUCCESSFULLY REMOVED. A MICRO GUIDEWIRE WAS SUBSEQUENTLY USED TO MASSAGE THE STENT TO ENSURE BETTER APPOSITION TO THE VESSEL WALL AND OPEN IT PERFECTLY. ROUTINE POSTOPERATIVE ANGIOGRAPHY REVEALED A GUIDEWIRE-LIKE SHADOW AT THE DISTAL END OF THE STENT, WHICH PERSISTED DESPITE REPEATED ANGLE ADJUSTMENTS. FURTHER INSPECTION OF THE STENT DELIVERY PUSHER SHOWED THAT THE TIP GUIDEWIRE WAS MISSING. AN ATTEMPT WAS IMMEDIATELY MADE TO RETRIEVE IT USING A THROMBECTOMY STENT, WITH 15 REPEATED RETRIEVAL ATTEMPTS, ALL UNSUCCESSFUL. GIVEN THAT THE OPERATION HAD LASTED 5 HOURS, THE PATIENT¿S BLOOD FLOW REMAINED PATENT WITHOUT THROMBOEMBOLIC EVENTS, SUBSEQUENT ANESTHESIA RESUSCITATION WAS PERFORMED. THE DOCTOR DID NOT SHAPE THE DELIVERY TIP PRIOR TO USING THE DEVICE IN THE PATIENT. THERE IS NO FURTHER TREATMENT PLANNED TO RETRIEVE THE TIP INSIDE THE PATIENT. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THE PATIENT HAS NO ABNORMAL CONDITIONS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79488 LVIS D INTRACRANIAL COIL-ASSIST STENT QCA MICROVENTION, INC. 214031-CAS-D 0000240778 00842429115954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention