BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURPASS STENT DELIVERY SYSTEM 4MMX30MM

    MDR report key: 8719407 · Received June 20, 2019

    Report

    Report Number
    3008881809-2019-00176
    Event Type
    Injury
    Date Received
    June 20, 2019
    Date of Event
    June 1, 2019
    Report Date
    July 23, 2019
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    UDI-DI
    07613252648796
    PMA / PMN Number
    P170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTRONIC DEVICE HISTORY RECORD (EDHR) REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, VISUAL, DIMENSIONAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. IN CASE OF THIS COMPLAINT, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL FACTOR WAS ASSIGNED TO THE AS REPORTED ISSUE PATIENT COMPLICATION, AS A DEVICE RELATED ROOT CAUSE DOES NOT APPLY AND THE ISSUE IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT THAT IS NOTED WITH THE DIRECTION FOR USE (DFU), DEVICE LABELING AND/OR RISK DOCUMENTATION. OUTCOMES ATTRIBUTED TO AE: UPDATED TO INCLUDE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES) EXECUTIVE SUMMARY: CORRECTED: INTRAOPERATIVE MILRINONE TREATMENT WAS GIVEN TO THE PATIENT ON THE FOLLOW UP ANGIOGRAPHY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT STENT WAS USED SUCCESSFULLY FOR ANEURYSM LOCATED IN THE OPHTHALMIC ARTERY; HOWEVER, TWO DAYS POST PROCEDURE, THE PATIENT EXPERIENCED VISION CHANGES. THE PATIENT¿S VISION IS IMPROVING ON ITS OWN AND AN INTRAOPERATIVE MILRINONE WAS GIVEN TO THE PATIENT ON THE FOLLOW UP ANGIOGRAPHY.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE REMAINS IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBJECT STENT WAS SUCCESSFULLY IMPLANTED DURING THE PROCEDURE; HOWEVER, TWO DAYS POST PROCEDURE, THE PATIENT EXPERIENCED VISION CHANGES. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512003 SURPASS STENT DELIVERY SYSTEM 4MMX30MM INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK 21131864 07613252648796

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R