BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN (SURPASS STREAMLINE)

    MDR report key: 8745594 · Received June 28, 2019

    Report

    Report Number
    3008881809-2019-00187
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    June 13, 2019
    Report Date
    December 16, 2019
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    PMA / PMN Number
    P170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT LONG DESCRIPTION: UNKNOWN (SURPASS STREAMLINE). CATALOG#: UNKNOWN. LOT/SERIAL NO.: UNKNOWN. 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.

    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, THE A PRODUCT RELATED ROOT CAUSE DOES NOT APPLY AND THE REPORTED ISSUE IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND/OR PATIENT CONDITION NOTED WITH THE DIRECTION FOR USE, PRODUCT LABELLING AND/OR RISK DOCUMENTATION FILES; THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WAS ASSIGNED TO THE AS REPORTED ISSUES PATIENT INTRACRANIAL HEMORRHAGE AND PATIENT VESSEL PERFORATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR AN ELECTIVE PROCEDURE FOR ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY (ICA). THE PATIENT HAD SEVERELY TORTUOUS ANATOMY. A STENT WAS USED TO STRAIGHT THE MICROCATHETER AND THEN THE SUBJECT FLOW DIVERTER WAS DEPLOYED SUCCESSFULLY. ON THE FINAL ANGIOGRAPHY RUN, IT WAS NOTICED THAT THE DISTAL VESSEL HAD A SLOW FLOW. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED BUT THE IMAGES WERE NOT CLEAR. INTEGRILIN WAS ADMINISTERED; HOWEVER, ON THE ANGIOGRAPHY RUN IT WAS NOTICED THAT THERE WAS A SUBARACHNOID HEMORRHAGE (SAH) IN THE DISTAL VASCULATURE. THE PHYSICIAN APPLIED A LITTLE GLUE TO TREAT THE RUPTURED VESSEL. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR AN ELECTIVE PROCEDURE FOR ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY (ICA). THE PATIENT HAD SEVERELY TORTUOUS ANATOMY. A STENT WAS USED TO STRAIGHT THE MICROCATHETER AND THEN THE SUBJECT FLOW DIVERTER WAS DEPLOYED SUCCESSFULLY. ON THE FINAL ANGIOGRAPHY RUN, IT WAS NOTICED THAT THE DISTAL VESSEL HAD A SLOW FLOW. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED BUT THE IMAGES WERE NOT CLEAR. INTEGRILIN WAS ADMINISTERED; HOWEVER, ON THE ANGIOGRAPHY RUN IT WAS NOTICED THAT THERE WAS A SUBARACHNOID HEMORRHAGE (SAH) IN THE DISTAL VASCULATURE. THE PHYSICIAN APPLIED A LITTLE GLUE TO TREAT THE RUPTURED VESSEL. NO OTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR AN ELECTIVE PROCEDURE FOR ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY (ICA). THE PATIENT HAD SEVERELY TORTUOUS ANATOMY. A STENT WAS USED TO STRAIGHT THE MICROCATHETER AND THEN THE SUBJECT FLOW DIVERTER WAS DEPLOYED SUCCESSFULLY. ON THE FINAL ANGIOGRAPHY RUN, IT WAS NOTICED THAT THE DISTAL VESSEL HAD A SLOW FLOW. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED BUT THE IMAGES WERE NOT CLEAR. INTEGRILIN WAS ADMINISTERED; HOWEVER, ON THE ANGIOGRAPHY RUN IT WAS NOTICED THAT THERE WAS A SUBARACHNOID HEMORRHAGE (SAH) IN THE DISTAL VASCULATURE. THE PHYSICIAN APPLIED A LITTLE GLUE TO TREAT THE RUPTURED VESSEL. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538505 UNKNOWN (SURPASS STREAMLINE) INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK 21323883

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R