BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17542194 · Received August 14, 2023

    Report

    Report Number
    2029214-2023-01374
    Event Type
    Injury
    Date Received
    August 14, 2023
    Date of Event
    November 3, 2021
    Report Date
    August 14, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: ZHANG, Q., XU, X.-L., SUN, Y.-L., WANG, Z.-W., LAI, X.-L., <(>&<)> XIONG, Y.ZHANG, Q., XU, X.-L., SUN, Y.-L., WANG, Z.-W., LAI, X.-L., <(>&<)> XIONG, Y.. BILATERAL CAVERNOUS SINUS DURAL ARTERIOVENOUS FISTULA WITH INITIAL OCULAR SYMPTOM A CASE REPORT. MEDICINE 100(46):E27892 2021. DOI:10.1097/MD.0000000000027892. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ZHANG Q, XU X-L, SUN Y-L, WANG Z-W, LAI X-L, XIONG Y. BILATERAL CAVERNOUS SINUS DURAL ARTERIOVENOUS FISTULA WITH INITIAL OCULAR SYMPTOM: A CASE REPORT. MEDICINE. 2021;100(46):E27892. DOI:10.1097/MD.0000000000027892. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX. THE PURPOSE OF THIS ARTICLE WAS TO RETROSPECTIVELY ANALYZE A CASE OF CAVERNOUS SINUS DURAL ARTERIOVENOUS FISTULA (CSDAVF) WITH OCULAR SYMPTOMS AS INITIAL SYMPTOMS, FOCUSING ON THE DIAGNOSIS, CLINICAL COURSE AND TREATMENT OUTCOME. A 42-YEAR-OLD FEMALE HAD CHIEF COMPLAINT THAT THE RIGHT EYEBALL HAD CONJUNCTIVAL CONGESTION FOR HALF A YEAR. SHE WAS GIVEN LEVOFLOXACIN EYE DROPS TO TREAT THE RIGHT EYE WITH ANTI-INFLAMMATORY TREATMENT, BUT THE SYMPTOMS DID NOT IMPROVE. CRANIAL MAGNETIC RESONANCE AND CEREBROVASCULAR IMAGING SHOWED THAT THE RIGHT LATERAL RECTUS MUSCLE WAS SLIGHTLY ENLARGED, THE RIGHT EYEBALL WAS PROMINENT, BUT THERE WAS NO ABNORMALITY IN THE BRAIN. BASED ON CLINICAL AND IMAGING EXAMINATIONS AND DIGITAL SUBTRACTION ANGIOGRAPHY (DSA), SHE WAS DIAGNOSED AS LOWFLOW CSDAVF. THE PATIENT RECEIVED INTERVENTIONAL EMBOLIZATION WITH TRANSVENOUS COMBINED ARTERIAL APPROACH USING COILS AND ONYX LIQUID GLUE. THE PATIENT¿S EXOPHTHALMOS AND CONGESTION SYMPTOMS WERE IMPROVED ON THE FIRST DAY AFTER SURGERY, AND HER VISION DID NOT CHANGE. AT THE TIME OF DISCHARGE, THE PATIENT WAS CONSCIOUS, SELF-REPORTED DIPLOPIA, GCS 15 POINTS, RIGHT EXOPHTHALMOS AND HYPEREMIA DISAPPEARED, BILATERAL PUPILS WERE 3.0 MM, SENSITIVE TO LIGHT, LIMBS ACTIVITY WAS NORMAL, MUSCLE STRENGTH LEVEL 5, MUSCLE TENSION WAS NORMAL, THE PHYSIOLOGICAL REFLEX WAS PRESENT, AND THE MENINGEAL IRRITATION AND PATHOLOGICAL SIGNS WERE NOT ELICITED.  DIPLOPIA AFTER SURGERY MAY BE RELATED TO LOCAL TISSUE EDEMA COMPRESSING THE OCULOMOTOR NERVE, WHICH RELIEVED 3WEEKS AFTER SURGERY, AND HER VISON ACUITY OF RIGHT EYE RECOVERED TO 0.5. AFTER HALF A YEAR OF FOLLOW-UP, MILD HEADACHE STILL PERSISTED, WHICH MAY BE CAUSED BY THE COMPRESSION OF THE EMBOLIC MATERIAL ON THE FIRST BRANCH OF THE TRIGEMINAL NERVE. THE PATIENT USED CARBAMAZEPINE FOR PAIN RELIEF.   THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -DIPLOPIA AND SENSITIVE TO LIGHT -LOCAL TISSUE EDEMA COMPRESSING THE OCULOMOTOR NERVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50003 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other