BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN (SURPASS STREAMLINE)

    MDR report key: 9474039 · Received December 16, 2019

    Report

    Report Number
    3008881809-2019-00391
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    August 27, 2019
    Report Date
    May 6, 2021
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    PMA / PMN Number
    P170024/S003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    CATALOG#: UNKNOWN, LOT/SERIAL NO.: UNKNOWN. THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED AND DEFORMED. DURING THE FUNCTIONING TEST, THE STENT WAS UNABLE TO BE RETRACTED INTO THE MICROCATHETER DUE TO THE SOLIDIFIED CONTRAST MEDIA. AS PER THE ADDITIONAL INFORMATION, THE SUBJECT DEVICE WAS IN GOOD CONDITION PRIOR TO USE AND THE PATIENT¿S ANATOMY WAS TYPE II TORTUOUS. A PROBABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED EVENT AND ANALYZED DEFECTS, AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU (DIRECTION FOR USE) BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED. THE NEUROVASCULAR STRYKER SURPASS EVOLVE DEVICE IS 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.

    Description of Event or Problem · 1

    DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268320 UNKNOWN (SURPASS STREAMLINE) INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR