BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN (SURPASS STREAMLINE)

    MDR report key: 9226591 · Received October 23, 2019

    Report

    Report Number
    3008881809-2019-00320
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    October 3, 2019
    Report Date
    December 16, 2019
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    PMA / PMN Number
    P170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT LONG DESCRIPTION: UNKNOWN (SURPASS STREAMLINE). 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 DIRECTION 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. THE DEVICE WAS RETURNED AND THE STENT DELIVERY WIRE (SDW) WAS KINKED. THE FLOW DIVERTER WAS FOUND TO BE PREMATURELY DEPLOYED WITHIN THE RETURNED XT-27 MICROCATHETER, DEFORMATION WAS ALSO NOTED TO THE FLOW DIVERTER. IT IS PROBABLE THAT THE DEVICE WAS DAMAGED DURING THE CLINICAL PROCEDURE CAUSING THE REPORTED EVENT. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WAS ASSIGNED TO THE REPORTED ISSUE STENT FAILED/ UNABLE TO OPEN AND TO THE ANALYZED ISSUES SDW KINKED/ BENT, STENT DEPLOYED PREMATURELY DURING USE AND STENT DEFORMED, 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 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). (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT DID NOT OPEN; THEREFORE, THE PHYSICIAN REMOVED THE STENT OUT OF THE PATIENT¿S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER STRYKER DEVICE. NO PATIENT CONSEQUENCES REPORTED DUE TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT DID NOT OPEN; THEREFORE, THE PHYSICIAN REMOVED THE STENT OUT OF THE PATIENT¿S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER STRYKER DEVICE. NO PATIENT CONSEQUENCES REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018859 UNKNOWN (SURPASS STREAMLINE) INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 XT-27 MICROCATHETER (STRYKER)