BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LVIS D

    MDR report key: 20306626 · Received September 25, 2024

    Report

    Report Number
    2032493-2024-00712
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    August 14, 2024
    Report Date
    November 25, 2024
    Manufacturer
    MICROVENTION, INC.
    Product Code
    QCA
    UDI-DI
    00842429115893
    PMA / PMN Number
    P170013
    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 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.

    Additional Manufacturer Narrative · 0

    ITEMS RETURNED FOR INVESTIGATION: STENT, PUSHER, INTRODUCER. ITEMS NOT RETURNED FOR INVESTIGATION: MICROCATHETER. THE STENT WAS RETURNED DETACHED IN THE INTRODUCER. THE STENT WAS ALSO PARTIALLY DEPLOYED FROM THE INTRODUCER. THE PUSHER WAS FOUND TO BE BROKEN AT THE DISTAL END AND EXHIBITED A ¿CONE¿ PROFILE. THE STENT WAS RETRIEVED FROM THE INTRODUCER INTACT. THE STENT WAS LOADED ONTO AN IN-HOUSE PUSHER WITH THE RETURNED INTRODUCER AND ADVANCE INTO AN IN-HOUSE MICROCATHETER FOR THE INVESTIGATION. THE STENT WAS ABLE TO ADVANCE AND RESHEATH WITHOUT RESISTANCE DURING THE INVESTIGATION. THE INVESTIGATION FOUND THE STENT RETURNED DETACHED FROM THE PUSHER AND PARTIALLY DEPLOYED FROM THE INTRODUCER SHEATH; FURTHERMORE, THE PUSHER WAS RETURNED BROKEN AT THE DISTAL END WHICH IS CONSISTENT WITH THE CONDITION DESCRIBED IN THE REPORTED EVENT. HOWEVER, THE STENT WAS ABLE TO BE RESHEATHED AND RETRACTED SUCCESSFULLY FROM AN IN-HOUSE MICROCATHETER WHEN LOADED ONTO AN UNDAMAGED IN-HOUSE PUSHER DURING FUNCTIONAL TESTING. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE PUSHER BREAK, BUT THIS DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES THAT EXCEEDED THE PUSHER'S TENSILE 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.

    Description of Event or Problem · 0

    AS REPORTED: THE LEFT POSTERIOR COMMUNICATING ANEURYSM WAS 4MM WIDE AND 3MM LONG, 3.02MM AT THE NECK OF THE ANEURYSM, 4.38MM AT THE DISTAL END OF THE VESSEL AND 3.7MM AT THE PROXIMAL END. THE PHYSICIAN PLANNED TO USE STENT 213517-CAS TO ASSIST ANEURYSM EMBOLIZATION. AFTER THE STENT WAS HYDRATED AND VENTED, THE STENT WAS DELIVERED TO THE PATIENT. WHEN THE STENT WAS RELEASED TO HALF THE FIRST TIME, THE STENT RELEASE WAS NOT SATISFACTORY. THE PHYSICIAN CONDUCTED A STENT RECOVERY PLAN TO RELEASE THE STENT AGAIN, BUT THE STENT COULD NOT BE RECOVERED INTO THE MICROCATHETER. SO, THE WHOLE WITHDRAWAL, FOUND THAT THE PUSHER RUPTURED. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT WITH THE SAME TYPE OF STENT. PATIENT STATUS IS FINE.

    Description of Event or Problem · 0

    AS REPORTED: THE LEFT POSTERIOR COMMUNICATING ANEURYSM WAS 4MM WIDE AND 3MM LONG, 3.02MM AT THE NECK OF THE ANEURYSM, 4.38MM AT THE DISTAL END OF THE VESSEL AND 3.7MM AT THE PROXIMAL END. THE PHYSICIAN PLANNED TO USE STENT 213517-CAS TO ASSIST ANEURYSM EMBOLIZATION. AFTER THE STENT WAS HYDRATED AND VENTED, THE STENT WAS DELIVERED TO THE PATIENT. WHEN THE STENT WAS RELEASED TO HALF THE FIRST TIME, THE STENT RELEASE WAS NOT SATISFACTORY. THE PHYSICIAN CONDUCTED A STENT RECOVERY PLAN TO RELEASE THE STENT AGAIN, BUT THE STENT COULD NOT BE RECOVERED INTO THE MICROCATHETER. SO, THE WHOLE WITHDRAWAL, THE IMPLANT STENT WAS DETACHED, IN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT WITH THE SAME TYPE OF STENT. PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304069 LVIS D INTRACRANIAL COIL-ASSIST STENT QCA MICROVENTION, INC. 213517-CAS-D 0000537121 00842429115893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MICROCATHETER.