BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 9608046 · Received January 20, 2020

    Report

    Report Number
    3008881809-2020-00010
    Event Type
    Injury
    Date Received
    January 20, 2020
    Date of Event
    November 13, 2019
    Report Date
    January 20, 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 · 1

    LOT/SERIAL NO.: UNKNOWN. 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. THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE, PHYSICAL AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION CURRENTLY AVAILABLE THE REPORTED RIGHT SIDED WEAKNESS (NEUROLOGICAL DEFICIT), THROMBOSIS AND TRANSIENT ISCHEMIC ATTACK ARE KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND PATIENT CONDITION, AND IS LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE. THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THE REPORTED EVENT. THE DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED RIGHT SIDED WEAKNESS 3 WEEKS POST THE FLOW DIVERTER (SUBJECT DEVICE) IMPLANTATION AT THE LEFT PARA-OPTHALMIC INTERNAL CAROTID ARTERY. ON INVESTIGATION, A THROMBOTIC EVENT WAS DISCOVERED AT LEFT PARA-OPTHALMIC INTERNAL CAROTID ARTERY WHICH LEADING TO THE TRANSIENT STROKE SYMPTOMS. INTERVENTION WAS REQUIRED AND THE IMPROVEMENT WAS NOTICED AFTER RE-INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71514 UNKNOWN_NEUROVASCULAR_PRODUCT INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R