BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDWIRE TEMPORARY OCCLUSION SYSTEM

    MDR report key: 5966158 · Received September 21, 2016

    Report

    Report Number
    1220452-2016-00063
    Event Type
    Injury
    Date Received
    September 21, 2016
    Date of Event
    April 1, 2014
    Report Date
    August 22, 2016
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DXE
    PMA / PMN Number
    K023878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE INFORMATION: A CASE OF CAROTID STENTING WITH PROLONGED ISCHEMIC SYMPTOMS BY TRANSIENT DISTAL BALLOON PROTECTION (JPN J STROKE 37: 417¿422, 2015) SUGURU YAMAGUCHI, M.D., PH.D.,1) AND KATSUHIRO NISHINO, M.D., PH.D.1) PUBLICATION DATE: NOVEMBER 25, 2015.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED BECAUSE OF RIGHT HAND WEAKNESS DUE TO SMALL CORTICAL INFARCTION AT LEFT PRECENTRAL GYRUS. NECK MR ANGIOGRAPHY REVEALED LEFT NECK INTERNAL CAROTID ARTERY STENOSIS. THE STENOTIC PART WAS FRAGILE PLAQUE WITH INTRA-PLAQUE HEMORRHAGES. CAROTID ARTERY STENTING (CAS) WAS PERFORMED APPROXIMATELY 2 MONTHS AFTER THE ONSET. BECAUSE FRAGILE PLAQUE WAS SUGGESTED, THE DISTAL PROTECTION WAS CHOSEN USING THE CAROTID GUARD-WIRE, NOT A FILTER. IMMEDIATELY AFTER THE DISTAL BALLOON WAS INFLATED ON TRIAL, THE PATIENT PRESENTED RIGHT SIDE HEMIPARESIS, APHASIA, AND CONSCIOUSNESS DISTURBANCE. A NON-MEDTRONIC CAROTID WALL STENT WAS PLACED IN A RAPID MANNER UNDER SEDATION. TOTAL OCCLUSION TIME WAS 8 MINUTES 50 SECONDS. AFTER THE DISTAL BALLOON BECAME DEFLATED, HIS SYMPTOMS DID NOT DISAPPEAR REGARDLESS OF ANY DISTAL EMBOLISMS IN THE FINAL ANGIOGRAPHY. THREE HOURS LATER, HIS RIGHT HEMIPARESIS WAS RECOVERED ALMOST FULLY, BUT HIS APHASIA CONTINUED. AT LAST, HIS NEUROLOGICAL DEFICITS DISAPPEARED COMPLETELY AFTER 2 DAYS. THE CAS PROCEDURE USING BALLOON PROTECTION HAS PROBLEMS ABOUT THE ISCHEMIC INTOLERANCE. COMMONLY, THE SYMPTOMS OF INTOLERANCE ARE IMPROVED RAPIDLY AFTER RESTORE PATENCY OF BLOOD FLOW. IN THIS CASE, ISCHEMIC SYMPTOMS PROLONGED FOR 2 DAYS IN SPITE OF CEREBRAL INFARCTION NOT BEING SEEN. IT WAS THOUGHT THAT THE ISCHEMIC INTOLERANCE PURELY CAUSED THIS SYMPTOM. GUARDWIRE TEMPORARY OCCLUSION <(>&<)> ASPIRATION SYSTEM IS INDICATED FOR CAROTID USE IN (B)(6) BUT IS THE SAME AS THE GUARDWIRE TEMPORARY OCCLUSION <(>&<)> ASPIRATION SYSTEM APPROVED IN US WITH CORONARY INDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619276 GUARDWIRE TEMPORARY OCCLUSION SYSTEM CATHETER, EMBOLECTOMY DXE MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization