BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 14498128 · Received May 25, 2022

    Report

    Report Number
    3012931345-2022-00113
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    June 18, 2019
    Report Date
    June 24, 2022
    Manufacturer
    STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER REMAINS UNKNOWN, THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS VISUAL TESTING CANNOT BE PERFORMED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS 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 REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND IT COULD NOT BE DEFINITIVELY DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. BASED UPON MEDICAL REVIEW, THE HARM OBSERVED IN THIS COMPLAINT IS ANTICIPATED IN NATURE AS PER THE DEVICE RISK ASSESSMENT. AS A PRODUCT RELATED ROOT CAUSE DOES NOT APPLY AND THE ISSUE IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND/OR PATIENT CONDITION NOTED WITHIN THE DFU, PRODUCT LABELING AND/OR RISK DOCUMENTATION FILES, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WILL BE ASSIGNED TO THIS COMPLAINT.

    Description of Event or Problem · 0

    IN A RETROSPECTIVE STUDY TO DETERMINE THE "INITIAL EXPERIENCE OF ACE68 REPERFUSION CATHETER IN PATIENTS WITH ACUTE ISCHEMIC STROKE RELATED TO INTERNAL CAROTID ARTERY OCCLUSION", 75 PATIENTS WHO RECEIVED ENDOVASCULAR TREATMENT (EVT) FOR INTERNAL CAROTID ARTERY OCCLUSION USING PENUMBRA ASPIRATION CATHETERS BETWEEN JANUARY 2015 AND DECEMBER 2018 WERE INCLUDED. OUT OF 75 PATIENTS, 15 PATIENTS DEVELOPED SYMPTOMATIC HEMORRHAGE WHERE PROCEDURE-RELATED SYMPTOMATIC HEMORRHAGE WAS DEFINED AS THE PRESENCE OF HEMORRHAGE AFTER EVT WITH ANY INCREASE IN THE NIHSS COMPARED TO BASELINE ON ADMISSION. MULTIPLE DEVICES WERE USED IN DIFFERENT PATIENTS AND THERE WAS NO DEFINITIVE EVIDENCE IN THE ARTICLE TO CONCLUDE OR DENY THAT THE ADVERSE EVENT WAS RELATED TO THE SUBJECT DEVICE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE OR PATIENT INFORMATION FROM THE ARTICLE, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS, IF ANY. THEREFORE, THIS REPORT ADDRESSES ALL SYMPTOMATIC HEMORRHAGIC EVENTS COVERED WITHIN THIS LITERATURE SOURCE.

    Description of Event or Problem · 0

    IN A RETROSPECTIVE STUDY TO DETERMINE THE "INITIAL EXPERIENCE OF ACE68 REPERFUSION CATHETER IN PATIENTS WITH ACUTE ISCHEMIC STROKE RELATED TO INTERNAL CAROTID ARTERY OCCLUSION", 75 PATIENTS WHO RECEIVED ENDOVASCULAR TREATMENT (EVT) FOR INTERNAL CAROTID ARTERY OCCLUSION USING PENUMBRA ASPIRATION CATHETERS BETWEEN (B)(6) 2015 AND (B)(6) 2018 WERE INCLUDED. OUT OF 75 PATIENTS, 15 PATIENTS DEVELOPED SYMPTOMATIC HEMORRHAGE WHERE PROCEDURE-RELATED SYMPTOMATIC HEMORRHAGE WAS DEFINED AS THE PRESENCE OF HEMORRHAGE AFTER EVT WITH ANY INCREASE IN THE NIHSS COMPARED TO BASELINE ON ADMISSION. MULTIPLE DEVICES WERE USED IN DIFFERENT PATIENTS AND THERE WAS NO DEFINITIVE EVIDENCE IN THE ARTICLE TO CONCLUDE OR DENY THAT THE ADVERSE EVENT WAS RELATED TO THE SUBJECT DEVICE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE OR PATIENT INFORMATION FROM THE ARTICLE, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS, IF ANY. THEREFORE, THIS REPORT ADDRESSES ALL SYMPTOMATIC HEMORRHAGIC EVENTS COVERED WITHIN THIS LITERATURE SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1891887 UNKNOWN_NEUROVASCULAR_PRODUCT WIRE, GUIDE, CATHETER DQX STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other 054 REPERFUSION CATHETER (PENUMBRA).| 4MAX REPERFUSION CATHETER (PENUMBRA).| 5MAX REPERFUSION CATHETER (PENUMBRA).| ACE68 REPERFUSION CATHETER (PENUMBRA).| GUIDER SOFTIP CATHETER (STRYKER).| REBAR 18 MICROCATHETER(EV3).| SHUTTLE-SL 8FR SHUTTLE SHEATH (COOK).| SOLITAIRE STENT RETRIEVAL SYSTEM.