BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LVIS D 2.5X17

    MDR report key: 16891881 · Received May 8, 2023

    Report

    Report Number
    2032493-2023-00714
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    April 5, 2023
    Report Date
    July 12, 2023
    Manufacturer
    MICROVENTION, INC
    Product Code
    QCA
    UDI-DI
    00812636020075
    PMA / PMN Number
    P170013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ITEMS RETURNED FOR INVESTIGATION: STENT, PUSHER, INTRODUCER ITEMS NOT RETURNED FOR INVESTIGATION: MICROCATHETER. THE STENT WAS RETURNED FULLY DEPLOYED. THE PROXIMAL MARKER BAND OD IS SPECIFIED AT 0.0175¿ (+/-0.0003) AND THE RETURNED PUSHER WAS MEASURED AT 0.0177¿; THE DISTAL MARKER BAND OD IS SPECIFIED AT 0.0125¿ (+/-0.0003) AND THE RETURNED PUSHER WAS MEASURED AT 0.0123¿. THE INTRODUCER DISTAL TIP ID IS SPECIFIED AT 0.0215¿; THE RETURNED INTRODUCER WAS SLIGHTLY DAMAGED AT THE DISTAL TIP AND MEASURED 0.0202¿. THE STENT WAS LOADED ONTO THE RETURNED PUSHER WITH THE RETURNED INTRODUCER AND ADVANCED INTO A NEW MICROCATHETER FOR THE INVESTIGATION; THE STENT SUCCESSFULLY ENTERED THE MICROCATHETER AND WAS RESHEATHED INTO THE INTRODUCER SEVERAL TIMES. THE STENT WAS ABLE TO DEPLOY AND RETRACT SUCCESSFULLY DURING THE INVESTIGATION. THE INVESTIGATION OF THE RETURNED STENT SYSTEM FOUND THE INTRODUCER TIP SLIGHTLY DAMAGED; HOWEVER, THE DEVICE WAS ABLE TO SUCCESSFULLY ADVANCE THROUGH THE RETURNED INTRODUCER AND THROUGH AN IN-HOUSE MICROCATHETER, AND FULLY OPEN UPON DEPLOYMENT DURING FUNCTIONAL TESTING. THE STENT WAS ABLE TO SUCCESSFULLY RESHEATHED INTO THE RETURNED INTRODUCER DURING THE INVESTIGATION. THE DAMAGE TO THE INTRODUCER DISTAL TIP IS CONSISTENT WITH EXCESSIVE FORCE USED IN SEATING THE INTRODUCER IN THE HUB OF THE MICROCATHETER DURING THE PROCEDURE. THE MICROCATHETER USED IN THE PROCEDURE WAS NOT EVALUATED AS A PART OF THIS EVALUATION, SO THE INVESTIGATION COULD NOT DETERMINE IF IT HAD CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS STATED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RETURNED. THE ALLEGED RESHEATHING ISSUE 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. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE STENT DEPLOYED OUT OF THE CATHETER BUT WOULD NOT TOTALLY RE-SHEATH DURING TREATMENT FOR POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE STENT ENTERED THE LESION SITE THROUGH THE MICROCATHETER BUT AFTER ADJUSTING THE POSITION MULTIPLE TIMES, THE STENT WAS UNABLE TO BE RESHEATHED. THE STENT WAS HALF RELEASED FROM THE DELIVERY SYSTEM BUT DID NOT DETACH BEFORE IT WAS REMOVED WITH THE CATHETER. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER TOGETHER THEN COMPLETED THE PROCEDURE AFTER REPLACING BOTH STENT AND MICROCATHETER. IT IS REPORTED THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1954202 LVIS D 2.5X17 INTRALUMINAL DEVICES QCA MICROVENTION, INC 212517-CAS-D-CN 0000226182 00812636020075

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female