BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17351212 · Received July 19, 2023

    Report

    Report Number
    2029214-2023-01141
    Event Type
    Injury
    Date Received
    July 19, 2023
    Date of Event
    August 1, 2009
    Report Date
    July 19, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ASSOCIATED WITH MDR#: 2029214-2023-01140. A2: THE REPORTED PATIENT AGE IS THE MEAN AGE OF ALL PATIENTS INCLUDED IN THE STUDY. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    HUANG, Q., XU, Y., HONG, B., LI, Q., ZHAO, W., LIU, J. (2009). USE OF ONYX IN THE MANAGEMENT OF TENTORIAL DURAL ARTERIOVENOUS FISTULAE. NEUROSURGERY, 65(2), 287¿292. HTTPS://DOI.ORG/10.1227/01. NEU.0000348298.75128.D0. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND THAT 14 PATIENTS UNDERWENT EMBOLIZATION PROCEDURES WITH ONYX TO TREAT TENTORIAL DURAL ARTERIOVENOUS FISTULAS (DAVFS). OF THE 14 PATIENTS, 12 PATIENTS PRESENTED WITH SUBARACHNOID HEMORRHAGE (SAH) OR INTRAVENTRICULAR HEMORRHAGE (IVH). THE TWO OTHER PATIENTS PRESENTED WITH COMPLAINTS OF PROGRESSIVE HEADACHES OR DIZZINESS. AFTER PLACEMENT OF THE MICROCATHETER, ONYX WAS INJECTED USING THE "REFLUX-HOLD-REINJECTION" TECHNIQUE. WHEN UNWANTED REFLUX OF ONYX OR FLOW TOWARD UNDESIRABLE VESSELS WAS OBSERVED, THE INJECTION WAS HELD FOR 20 SECONDS TO 2 MINUTES TO SOLIDIFY THE ONYX AND THEN INJECTION WAS RESTARTED. DURING THE INJECTION OF ONYX, ANGIOGRAPHY WAS PERFORMED THROUGH THE GUIDING CATHETER OR ANGIOGRAPHIC CATHETER TO CONFIRM THE TOTAL OCCLUSION OF FISTULA AND UNDESIRABLE EMBOLIZATION. THE MICROCATHETERS WERE WITHDRAWN WHEN THE ANGIOGRAM SHOWED COMPLETE OCCLUSION OF THE FISTULA OR EXCESSIVE REFLUX OF ONYX. SERIOUS INJURIES REPORTED IN THE ARTICLE ARE NOTED BELOW: ONE 42-YEAR-OLD MALE PATIENT HAD INCOMPLETE OCCLUSION AFTER THE PROCEDURE WHICH WAS COMPLETED VIA THE LEFT POSTERIOR CEREBRAL ARTERY AND UNDERWENT RETREATMENT. AFTER THE INDEX ONYX EMBOLIZATION PROCEDURE, MILD RESIDUAL FILLING VIA THE RIGHT INTERNAL CAROTID ARTERY (ICA) WAS OBSERVED. FOLLOW-UP ANGIOGRAPHY PERFORMED 9 MONTHS LATER REVEALED RESIDUAL FILLING OF THE FISTULA. A SECOND ONYX EMBOLIZATION WAS PERFORMED VIA THE LEFT ICA FOR SUCCESSFUL COMPLETE OCCLUSION. A 65-YEAR-OLD MALE PATIENT HAD THE CATHETER RETAINED IN THE PROCEDURE. HOWEVER, NO ADDITIONAL INTERVENTION WAS REPORTED AND IT WAS NOTED THAT THE PATIENT HAD TOTAL OBLITERATION OF THE DAVF AND CLINICAL OUTCOME WAS EXCELLENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35601 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention| O