BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 9513649 · Received December 23, 2019

    Report

    Report Number
    3008881809-2019-00407
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    September 25, 2019
    Report Date
    December 23, 2019
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    PMA / PMN Number
    170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE AUTOMATED MES SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE REPORTED EVENT IS COVERED IN THE DEVICE 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. THE FLOW DIVERTER STENT (SUBJECT DEVICE) WAS RETURNED IN ITS DEPLOYED STATE WITH NO ANOMALIES. A FUNCTIONAL TEST COULD NOT BE PERFORMED AS THE STENT HAD BEEN DEPLOYED. THE RETURNED ASSOCIATED MICROCATHETER WAS NOTED TO BE DAMAGED TO THE DISTAL END. IT IS PROBABLE THAT THE MICROCATHETER WAS DAMAGED DURING THE CLINICAL PROCEDURE CAUSING THE REPORTED UNEXPECTED MOVEMENT OF DEVICE AND DIFFICULTY TO PULL STENT BACK INTO SHEATH. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE INVESTIGATION 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. 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

    BASED ON THE INVESTIGATION OF THE RETURNED PRODUCT, IT WAS FOUND THAT THE STENT PREMATURELY DEPLOYED INSIDE THE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306084 UNKNOWN_NEUROVASCULAR_PRODUCT INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR