BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM ATLAS 3.0MM X 24MM NO TIP - CE

    MDR report key: 20621249 · Received November 6, 2024

    Report

    Report Number
    3008881809-2024-00531
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    September 30, 2024
    Report Date
    December 17, 2024
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    QCA
    PMA / PMN Number
    P180031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D3 MANUFACTURER ENTITY - CORRECTED FORM STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TO STRYKER NEUROVASCULAR CORK. H3 DEVICE EVALUATED BY MFG ¿UPDATED. DUE TO THE AUTOMATED MES (MANUFACTURING EXECUTION SYSTEM) SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION, THE STENT WAS RETURNED WITHIN THE MICROCATHETER AND WAS FOUND DEPLOYED IN THE CATHETER SHAFT. THE SDW (STENT DELIVERY WIRE) WAS FOUND TO BE KINKED/BENT. THE STENT WAS FOUND TO BE DEFORMED. THE STENT INTRODUCER SHEATH WAS NOT RETURNED. THE MICROCATHETER WAS INTACT. A FUNCTIONAL INSPECTION FOR THE AS REPORTED 'STENT DEPLOYED PREMATURELY DURING USE' WAS NOT PERFORMED- IT WAS CONFIRMED DURING VISUAL INSPECTION. A FUNCTIONAL INSPECTION FOR THE AS REPORTED 'STENT DIFFICULT/UNABLE TO TRANSFER' COULD NOT BE PERFORMED AS THE STENT WAS DEPLOYED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. THE REPORTED 'STENT DEPLOYED PREMATURELY DURING USE' WAS VISUALLY CONFIRMED DURING INSPECTION OF THE MICROCATHETER SHAFT. THE REPORTED 'STENT DIFFICULT/UNABLE TO TRANSFER' COULD NOT BE REPLICATED AS THE STENT WAS NO LONGER LOADED ON THE SDW. HOWEVER, THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THE DEVICE WAS PREPARED AS PER THE DFU. THERE WAS NO DAMAGE NOTED TO THE PACKAGING PRIOR TO OPENING THE PACKAGING AND THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION PRIOR TO USE ON THE PATIENT. CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE. IT WAS REPORTED THAT THE OPERATOR 'USED STRYKER STENT TO SUPPORT COIL EMBOLIZATION. WHEN INSERTING THE STENT FROM INTRODUCING SHEATH TO GO INTO MICROCATHETER TIP OF THE STENT ENCOUNTERED BIG RESISTANCE. DURING ADJUSTMENTS THE STENT DEPLOYED IN HUB. SO REPLACED THE STENT WITH ANOTHER ATLAS IN SAME CATALOG TO GO THROUGH THE SL-10 TO DEPLOY AND FINISHED THE PROCEDURE'. IN A PRODUCT CONDITION UPDATE IT WAS CLARIFIED THAT 'THE LOCATION THAT THE STENT DEPLOYED AT WAS NOT HUB. IT WAS AT THE PROXIMAL OF THE MICROCATHETER. THE MICROCATHETER WITH BE RETURNED TOGETHER.' THE STENT WAS RETURNED FOR ANALYSIS FULLY DEPLOYED INSIDE THE PROXIMAL SHAFT OF THE MICROCATHETER. THE STENT WAS NO LONGER LOADED ON THE STENT DELIVERY WIRE (SDW). ONCE REMOVED FROM THE LUMEN, THE STENT WAS NOTED TO BE DEFORMED TOWARDS THE DISTAL (OPEN CELL) AND ALSO IN THE MIDDLE SECTION. THE STENT DELIVERY WIRE (SDW) WAS RETURNED AND WAS KINKED/BENT AT THE PROXIMAL AND DISTAL ENDS OF THE WIRE. THE INTRODUCER SHEATH WAS NOT RETURNED FOR ANALYSIS. GIVEN THE EVENT DESCRIPTION AND THE CONDITION OF THE ANALYZED DEVICE SUB-COMPONENTS, IT IS POSSIBLE THAT THE INTRODUCER SHEATH WAS INITIALLY SET UP CORRECTLY BUT SUBSEQUENTLY MOVED EITHER PROXIMALLY OR DISTALLY PRIOR TO STENT ADVANCEMENT OUT OF THE SHEATH (IT IS NOT POSSIBLE TO DECIDE WHICH DIRECTION THE MOVEMENT WAS IN AS THE INTRODUCER SHEATH WAS NOT RETURNED FOR ANALYSIS). IF THIS WERE TO OCCUR, IT IS LIKELY THAT, DURING ADVANCEMENT OF THE STENT TO TRANSFER IT FROM THE SHEATH INTO THE PROXIMAL END OF THE MICROCATHETER LUMEN, THE STENT WOULD PARTIALLY DEPLOY INTO THE GAP (PROXIMAL SHEATH MOVEMENT) OR THE STENT WOULD BECOME DAMAGED AS IT PASSES THROUGH THE DEFORMED DISTAL TIP OPENING OF THE SHEATH (DISTAL MOVEMENT). THE USER WILL THEN EXPERIENCE INCREASED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE STENT INTO THE MICROCATHETER, RESULTING IN DAMAGE TO THE STENT AND SDW. IN ATTEMPTING TO REMOVE THE STENT, IT IS FURTHER LIKELY THAT EXCESSIVE TRACKING REACTION FORCE CAUSED THE SDW TO SLIP THROUGH THE STENT. THIS IS ONE POSSIBLE EXPLANATION TO EXPLAIN THE ANALYSIS FINDINGS. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS HAS BEEN ASSIGNED TO THE 'AS REPORTED' AND 'AS ANALYZED' CODES AS THIS COMPLAINT APPEARS TO BE ASSOCIATED WITH A PRODUCT THAT MET THE MANUFACTURERS DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS REPORTED TO HAVE BEEN USED IN ACCORDANCE WITH THE DFU, BUT PERFORMANCE WAS LIMITED DUE TO PROCEDURAL FACTORS DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM EMBOLIZATION, THE SUBJECT STENT WAS USED TO SUPPORT COIL EMBOLIZATION. SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE STENT FROM THE INTRODUCING SHEATH TO THE TIP OF THE MICROCATHETER. DURING ADJUSTMENTS, THE STENT DEPLOYED PREMATURELY NEAR THE PROXIMAL END OF THE MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM EMBOLIZATION, THE SUBJECT STENT WAS USED TO SUPPORT COIL EMBOLIZATION. SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE STENT FROM THE INTRODUCING SHEATH TO THE TIP OF THE MICROCATHETER. DURING ADJUSTMENTS, THE STENT DEPLOYED PREMATURELY NEAR THE PROXIMAL END OF THE MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1860759 NEUROFORM ATLAS 3.0MM X 24MM NO TIP - CE INTRACRANIAL COIL-ASSIST STENT QCA STRYKER NEUROVASCULAR CORK 24950908

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SL-10 CATHETER (STRYKER).