BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN (SURPASS STREAMLINE)

    MDR report key: 8667484 · Received June 4, 2019

    Report

    Report Number
    3008881809-2019-00153
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    May 20, 2019
    Report Date
    December 3, 2019
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    PMA / PMN Number
    P170024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. 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 NEUROLOGICAL DEFICITS AND TRANSIENT ISCHEMIC ATTACK (TIA) ARE KNOWN AND ANTICIPATED COMPLICATIONS AND IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU), THEREFORE, A CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WILL BE ASSIGNED. ADDITIONAL INFORMATION INDICATES THE ANATOMY OF THE PATIENT WAS TORTUOUS. IT IS MOST PROBABLE THAT PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING THE PROCEDURE CONTRIBUTED TO THE REPORTED STENT IMPROPERLY DEPLOYED. THEREFORE, A CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED, AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE DEVICE PERFORMANCE WAS LIMITED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SUFFERED A TRANSIENT ISCHEMIC ATTACK (TIA) AND SYMPTOMS OF BRACHIOFACIAL MOTOR DEFICIT POST PROCEDURE. THE PHYSICIAN ADMINISTERED AGRASTAT IV (ANTICOAGULANT) AS MEDICAL INTERVENTION AND REMAINS HOSPITALIZED FOR OBSERVATION. ADDITIONAL INFORMATION REPORTED THAT THE STENT WAS NOT DEPLOYED IN THE CORRECT POSITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SUFFERED A TRANSIENT ISCHEMIC ATTACK (TIA) AND SYMPTOMS OF BRACHIOFACIAL MOTOR DEFICIT POST PROCEDURE. THE PHYSICIAN ADMINISTERED AGRASTAT IV (ANTICOAGULANT) AS MEDICAL INTERVENTION AND REMAINS HOSPITALIZED FOR OBSERVATION. ADDITIONAL INFORMATION REPORTED THAT THE STENT WAS NOT DEPLOYED IN THE CORRECT POSITION.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED A TRANSIENT ISCHEMIC ATTACK (TIA) AND SYMPTOMS OF BRACHIOFACIAL MOTOR DEFICIT POST PROCEDURE. THE PHYSICIAN ADMINISTERED AGRASTAT IV (ANTICOAGULANT) AS MEDICAL INTERVENTION AND REMAINS HOSPITALIZED FOR OBSERVATION. THE RELATIONSHIP BETWEEN THE DEVICE AND THE PATIENT EVENT IS UNKNOWN AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460657 UNKNOWN (SURPASS STREAMLINE) INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK 21280814

    Patients

    Seq Age Sex Outcome Treatment
    1 BALLOON CATHETER (STRYKER)