BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 10012265 · Received April 29, 2020

    Report

    Report Number
    3008881809-2020-00122
    Event Type
    Malfunction
    Date Received
    April 29, 2020
    Date of Event
    February 6, 2020
    Report Date
    April 29, 2020
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    PMA / PMN Number
    P170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE AUTOMATED MES SYSTEM (MANUFACTURING EXECUTION SYSTEM), THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE DEVICE WAS RETURNED WITH AN XT-27 MICROCATHETER. VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE AND IT WAS OBSERVED THAT THE DISTAL 6CM SECTION OF THE RETURNED XT-27 MICROCATHETER WAS BROKEN/FRACTURED AND FLATTENING/CRUSHING NOTED TO THE DISTAL 15CM OF THE MICROCATHETER. DURING FUNCTIONAL TESTING, A PATENCY MANDREL WAS ADVANCED THROUGH THE RETURNED XT-27 AND THE SURPASS EVOLVE FLOW DIVERTER WAS REMOVED FROM THE MICROCATHETER. THE SURPASS EVOLVE FLOW DIVERTER WAS FOUND TO BE DEPLOYED AND DEFORMED WITHIN THE XT-27 MICROCATHETER LUMEN. THE REPORTED EVENT WAS CONFIRMED. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. THE REPORTED EVENT IS COVERED IN THE DEVICE 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. IT IS PROBABLE THAT THE XT-27 MICROCATHETER WAS DAMAGED DURING THE CLINICAL PROCEDURE CAUSING DIFFICULTIES IN DEPLOYING THE FLOW DIVERTER AND CAUSING PREMATURE DEPLOYMENT OF THE FLOW DIVERTER WITHIN THE XT-27 DURING THE ATTEMPT TO REMOVE FROM THE PATIENT. AN ASSIGNABLE CAUSE OF CAUSED BY OTHER WILL BE ASSIGNED TO THE REPORTED AND ANALYZED ISSUES. THE NEUROVASCULAR STRYKER SURPASS EVOLVE DEVICE IS NOT CURRENTLY APPROVED OR COMMERCIALLY SOLD IN THE USA. THE EVENT FOR THE SURPASS EVOLVE DEVICE WAS FILED TO FDA AS A SIMILAR PRODUCT TO STRYKER DEVICE SURPASS STREAMLINE DEVICE THAT IS COMMERCIALLY AVAILABLE IN THE US (PMA # P170024). SEE SECTION 4.11.3 GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF, NOVEMBER 8, 2016. THIS IS THE FIRST OF 2 REPORTS.

    Description of Event or Problem · 1

    BASED ON THE RETURN OF THE DEVICES, IT WAS OBSERVED THAT THE STENT (SUBJECT DEVICE) WAS PREMATURELY DEPLOYED INSIDE THE FLATTENED AND BROKEN CATHETER. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475444 UNKNOWN_NEUROVASCULAR_PRODUCT INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 EXCELSIOR XT-27 MICROCATHETER