BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 20285927 · Received September 23, 2024

    Report

    Report Number
    2029214-2024-01622
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    October 9, 2023
    Report Date
    September 23, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED PATIENT AGE (65 YEARS) IS REPRESENTATIVE OF THE MEAN AGE OF ALL PATIENT IN THE STUDY ARTICLE. REPORTED PATIENT SEX IS REPRESENTATIVE OF THE MAJORITY OF PATIENTS IN THE STUDY (42 MALES AND 14 FEMALES). REPORTED EVENT DATE IS THE DATE OF THE ARTICLE EARLIEST ELECTRONIC PUBLICATION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MA, L., REN, H.-C., HUANG, Y., <(>&<)> YIN, L. (2024). HYBRID SURGERY FOR REVASCULARIZATION OF CHRONIC OCCLUSION OF INTERNAL CAROTID ARTERY. THE JOURNAL OF CRANIOFACIAL SURGERY, 35(1), 168¿171. HTTPS://DOI.ORG/10.1097/SCS.0000000000009760. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A REVIEW WHICH WAS CONDUCTED TO HELP DETERMINE THE SAFETY AND EFFECTIVENESS OF HYBRID SURGERY FOR REVASCULARIZATION OF CHRONIC OCCLUSION OF THE INTERNAL CAROTID ARTERY (ICA) AND REPORTS SUCCESSFUL OPERATIONS WITH IMPROVED INTRACRANIAL BLOOD FLOW. THE HYBRID TECHNIQUE INCLUDED CONFIRMATION OF THE ICA OCCLUSION/PLAQUE, INTENTIONAL DISSECTION OF THE ICA FOR REMOVAL OF ATHEROSCLEROTIC PLAQUE, AND PLACEMENT OF ICA STENT. IT WAS NOTED THAT ECHELON-10 MICRO CATHETERS WERE USED IN THE PROCEDURES. 56 PATIENTS UNDERWENT HYBRID SURGERY FOR REVASCULARIZATION OF CHRONIC OCCLUSION OF THE ICA. THERE WAS NO DEVICE ISSUE REPORTED INTRA-OPERATIVELY IN THE LITERATURE ARTICLE. NO PATIENT MORTALITY WAS REPORTED. ALL OF THE FOLLOW-UP EXAMINATIONS SHOWED THAT THE RESPONDING VASCULAR WERE UNOBSTRUCTED AND CTP SHOWED IMPROVED INTRACRANIAL PERFUSION. ADVERSE EVENTS REPORTED IN THE ARTICLE INCLUDED: ¿ ONE PATIENT HAD FRESH INFARCTION OBSERVED ON POST-OPERATIVE BRAIN MAGNETIC RESONANCE IMAGING (MRI) WITHIN 24 HOURS OF THE INDEX PROCEDURE. HOWEVER, IT WAS NOTED THAT THE PATIENT HAD NO ASSOCIATED CLINICAL SYMPTOMS. ¿ THREE PATIENTS DEVELOPED SYMPTOMS OF IPSILATERAL NEURAL-FUNCTIONAL DEFECTS INCLUDING THE HYPOGLOSSAL NERVE, SUPERIOR LARYNGEAL NERVE, AND MANDIBULAR BRANCH OF THE FACIAL NERVE. THESE SYMPTOMS RESOLVED WITHIN TWO WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502720 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ECHELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other