BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURPASS EVOLVE 4.5MM X 15MM - CE

    MDR report key: 9607084 · Received January 20, 2020

    Report

    Report Number
    3008881809-2020-00009
    Event Type
    Injury
    Date Received
    January 20, 2020
    Date of Event
    December 24, 2019
    Report Date
    February 24, 2020
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    PMA / PMN Number
    P170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. H4 MANUFACTURING DATE: ADDED. D4 EXPIRATION DATE: ADDED. AT STRYKER MODEL FARM ROAD, THE EDHR (ELECTRONIC DEVICE HISTORY RECORD) FOR EACH LOT IS CREATED AND MAINTAINED IN MES (MANUFACTURING EXECUTION SYSTEM). AUTOMATED CONTROLS WITHIN THE MES SYSTEM ENSURE THAT ALL PRODUCT IS MANUFACTURED IN ACCORDANCE TO THE DMR (DEVICE MASTER RECORD).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. AS THE DEVICE REMAINS IMPLANTED AND NOT RETURNED FOR ANALYSIS; A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. HOWEVER, THE REPORTED EVENTS OF DIZZINESS, VISUAL DISTURBANCES, AND MILD HEADACHE POST PROCEDURE ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE NOTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS WAS ASSIGNED TO THIS EVENT. H3 OTHER TEXT : REMAINED IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT POST-PROCEDURE WITH A FLOW DIVERTER STENT (SUBJECT DEVICE), ABOUT A WEEK PRIOR TO CEASING THE PLATELET INHIBITOR MEDICATION EFFIENT, THE PATIENT EXPERIENCED QUITE A LOT OF DIZZINESS. WHEN THE PLATELET INHIBITOR TREATMENT WAS FINISHED, THE PATIENT EXPERIENCED 3 AURAS EPISODES IN TOTAL LASTING 25 MINUTES EACH. FOLLOWING EACH AURA, THERE WAS A MILD HEADACHE AND THE FEELING OF BEING A LITTLE OFF. ACCORDING TO THE PHYSICIAN, THE ADVERSE EVENTS WERE NOT SERIOUS AND IT IS UNKNOWN WHAT THE CONTRIBUTING FACTORS WERE. 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. REMAINED IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-PROCEDURE WITH A FLOW DIVERTER STENT (SUBJECT DEVICE), ABOUT A WEEK PRIOR TO CEASING THE PLATELET INHIBITOR MEDICATION EFFIENT, THE PATIENT EXPERIENCED QUITE A LOT OF DIZZINESS. WHEN THE PLATELET INHIBITOR TREATMENT WAS FINISHED, THE PATIENT EXPERIENCED 3 AURAS EPISODES IN TOTAL LASTING 25 MINUTES EACH. FOLLOWING EACH AURA, THERE WAS A MILD HEADACHE AND THE FEELING OF BEING A LITTLE OFF. ACCORDING TO THE PHYSICIAN, THE ADVERSE EVENTS WERE NOT SERIOUS AND IT IS UNKNOWN WHAT THE CONTRIBUTING FACTORS WERE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71783 SURPASS EVOLVE 4.5MM X 15MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other