BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN (SURPASS STREAMLINE)

    MDR report key: 9216568 · Received October 21, 2019

    Report

    Report Number
    3008881809-2019-00318
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    September 23, 2019
    Report Date
    December 3, 2019
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    PMA / PMN Number
    P170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT LONG DESCRIPTION: UNKNOWN (SURPASS STREAMLINE). CATALOG#: UNKNOWN. LOT/SERIAL NO.: UNKNOWN. THE NEUROVASCULAR STRYKER SURPASS EVOLVE DEVICE IS NOT CURRENTLY NOT 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. THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) HAS CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STABILIZER WAS RETURNED INSERTED IN AN XT- 27 MICRO CATHETER, THE DEVICE WAS ADVANCED THROUGH THE XT-27 WITHOUT ANY ISSUES, THE STENT WAS NOT RETURNED TO THE MANUFACTURING SITE AND THE STABILIZER WAS KINKED/BENT IN THE MID AREA AND AT THE DISTAL END. FUNCTIONAL TESTING COULD NOT BE PERFORMED AS ONLY THE STABILIZER WAS RETURNED. THE DEVICE WAS STATED TO BE IN GOOD CONDITION AND WAS PREPARED ACCORDING TO THE DFU SPECIFICATIONS. THE REPORTED ISSUE IS COVERED IN THE DEVICE DIRECTIONS FOR USE. 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 EVENT WAS CONFIRMED. IT IS PROBABLE THAT THE ANATOMICAL FACTORS PRESENT DURING THE CLINICAL PROCEDURE CAUSED FRICTION LEADING TO THE DEPLOYMENT ISSUE AND THE SUBSEQUENT DAMAGE NOTED TO THE DEVICE. THE DEVICE WAS RETURNED TO SITE DAMAGED AND NO STENT WAS RECEIVED. IT IS MOST LIKELY THAT THE 'PARTIALLY DEPLOYED STENT' WAS FULLY UNINTENTIONALLY DEPLOYED AND MIS-PLACED DURING THE PACKAGING OF THE DEVICE BACK TO SITE FOR ANALYSIS. THEREFORE, ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FLOW DIVERTING STENT(SUBJECT DEVICE) GOT STUCK INSIDE THE MICRO CATHETER AND DUE TO FRICTION THE STENT WAS ONLY DEPLOYED PARTIALLY AT THE TARGET LESION. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLOW DIVERTING STENT (SUBJECT DEVICE) GOT STUCK INSIDE THE MICRO CATHETER AND DUE TO FRICTION THE STENT WAS ONLY DEPLOYED PARTIALLY AT THE TARGET LESION. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010076 UNKNOWN (SURPASS STREAMLINE) INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 SYNCHRO GUIDEWIRE(STRYKER)| XT-27 MICROCATHETER(STRYKER)