BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN (SURPASS STREAMLINE)

    MDR report key: 9413813 · Received December 4, 2019

    Report

    Report Number
    3008881809-2019-00373
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    November 8, 2019
    Report Date
    January 28, 2020
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    PMA / PMN Number
    P170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D4: EXPIRATION DATE: ADDED. H4: MANUFACTURING DATE: ADDED. H3: DEVICE EVALUATED BY MFG: UPDATED. H3: SUMMARY ATTACHED: UPDATED. THE ELECTRONIC DEVICE HISTORY RECORD (EDHR) REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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. DURING VISUAL INSPECTION, THE SUBJECT FLOW DIVERTER WAS RETURNED INCORRECTLY INSERTED INSIDE XT-27 MICROCATHETER. NO ISSUE WAS NOTED WITH THE RETURNED MICROCATHETER. THE STENT WAS NOT RETURNED. RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE STENT DELIVERY WIRE (SDW). THE REPORTED COMPLAINT WAS CONFIRMED BASED AND DEVICE ANALYSIS. THE DEVICE FAILED TO MEET WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. AS PER THE AVAILABLE INFORMATION, THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. THE STENT WAS NOT RETURNED FOR ANALYSIS. IT IS PROBABLE THAT DEVICE FAILED TO OPEN, AND THE FRICTION NOTED DURING THE ANALYSIS OF THE RETURNED DEVICE WAS DUE TO THE TORTUOSITY OF THE PATIENT¿S ANATOMY CAUSING THE REPORTED EVENT. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED ISSUE STENT FAILED/ UNABLE TO OPEN AND THE ANALYZED ISSUE SDW FRICTION, AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE THE FLOW DIVERTER DID NOT FULLY EXPAND INSIDE THE PATIENT¿S ANATOMY. THERE WERE NO CLINICAL CONSEQUENCES DUE TO THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    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 SUBJECT DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE FLOW DIVERTER DID NOT FULLY EXPAND INSIDE THE PATIENT¿S ANATOMY. THERE WERE NO CLINICAL CONSEQUENCES DUE TO THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206608 UNKNOWN (SURPASS STREAMLINE) INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR AXS CATALYST 5 DISTAL ACCESS CATHETER (STRYKER)| XT-27 MICROCATHETER (STRYKER)