BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP

    MDR report key: 8609730 · Received May 14, 2019

    Report

    Report Number
    3008881809-2019-00126
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Date of Event
    March 5, 2019
    Report Date
    May 14, 2019
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    PMA / PMN Number
    H020002/S046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) HAS CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE STENT WAS RETURNED WITH THE STRYKER MICROCATHETER USED DURING THE PROCEDURE. VISUAL AND MICROSCOPIC INSPECTION OF THE DEVICE FOUND THAT THE INTRODUCER SHEATH WAS NOT RETURNED. WHEN A PATENCY MANDREL WAS ADVANCED THROUGH THE MICROCATHETER, THE STENT CAME OUT AND WAS NOTED TO BE DEFORMED. THERE WERE NO ANOMALIES NOTED TO THE STENT DELIVERY WIRE (SDW). FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED DEVICE. THE STENT WAS RETURNED PREMATURELY DEPLOYED WITHIN THE STRYKER XT-27 MICROCATHETER. PER THE DEVICE DIRECTIONS FOR USE (DFU): "REQUIRED ACCESSORIES: STANDARD INTERVENTIONAL DEVICES, INCLUDING ROTATING HEMOSTATIC VALVES =4.5F, A GUIDE CATHETER, GUIDEWIRE(S), AND STRYKER NEUROVASCULAR 0.0165-0.017 IN (0.42-0.43 MM) ID MICROCATHETERS, EXCLUDING TRACKER 17. THE MICROCATHETER USED DURING THE PROCEDURE WAS A 0.027 INCH INTERNAL DIAMETER CATHETER. THE INVESTIGATION CONFIRMED THAT THERE WAS AN ACT OR OMISSION OF AN ACT THAT RESULTED IN A DIFFERENT MEDICAL PRODUCT RESPONSE THAN INTENDED BY THE MANUFACTURER AND/OR EXPECTED BY THE USER. BASED ON THE INFORMATION AVAILABLE, AN ASSIGNABLE CAUSE OF USE ERROR WAS ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE STENT HAD PREMATURELY DEPLOYED DURING USE. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402557 NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK 20864788

    Patients

    Seq Age Sex Outcome Treatment
    1