BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17442641 · Received August 2, 2023

    Report

    Report Number
    2029214-2023-01270
    Event Type
    Injury
    Date Received
    August 2, 2023
    Date of Event
    January 20, 2017
    Report Date
    August 2, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: ALVARADO, A. M., HAUSSEN, D. C., EBERSOLE, K., NOGUEIRA, R. G., <(>&<)> ABRAHAM, M. G.. EMBOLIZATION OF SACRAL DURAL ARTERIOVENOUS FISTULAS: A CASE SERIES AND LITERATURE REVIEW. INTERVENTIONAL NEUROLOGY 6(1-2):73-81 2017. DOI:10.1159/000454929 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

    ALVARADO AM, HAUSSEN DC, EBERSOLE K, NOGUEIRA RG, ABRAHAM MG. EMBOLIZATION OF SACRAL DURAL ARTERIOVENOUS FISTULAS: A CASE SERIES AND LITERATURE REVIEW. INTERVENTIONAL NEUROLOGY. 2017;6(1-2):73-81. DOI:10.1159/000454929 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX. THE PURPOSE OF THIS ARTICLE WAS TO REPORT 2 CASES OF SACRAL DURAL ARTERIOVENOUS FISTULA (AVF) PRESENTING WITH GRADUAL NEUROLOGIC DECLINE CHARACTERIZED BY PROGRESSIVE LOWER EXTREMITY WEAKNESS AND BOWEL AND BLADDER INCONTINENCE.  A 69-YEAR-OLD MAN HAD A LONGITUDINALLY EXTENSIVE AND EXPANSIVE T2 HYPERINTENSE LESION FROM T7 TO THE CONUS MEDULLARIS. THROUGH A 5-FR MIKAELSSON CATHETER (ANGIODYNAMICS), AN ECHELON-14 MICROCATHETER (EV3 INC.) WAS NAVIGATED 4 MM FROM THE FISTULOUS POINT, AND DMSO (DIMETHYL SULFOXIDE; 0.5 ML) AND ETHYLENE VINYL ALCOHOL (ONYX-18; EV3 INC.; 0.8 ML) WERE INJECTED UNDER NEGATIVE ROADMAP GUIDANCE. THE LIQUID EMBOLIC AGENT REACHED THE VENOUS SYSTEM AND PROVIDED REASONABLY DENSE OPACIFICATION OF THE VEIN. THE MICROCATHETER WAS CAREFULLY RETRACTED AND A FINAL ANGIOGRAM SHOWED VERY LATE CONTRAST OPACIFICATION OF THE DRAINING VEIN, POTENTIALLY INDICATING A RESIDUAL SMALL FISTULA. DESPITE ENDURANCE AND STRENGTH IMPROVEMENT, A FOLLOW-UP ANGIOGRAM PERFORMED 6 WEEKS AFTER THE EMBOLIZATION REVEALED RESIDUAL FISTULA FILLING FROM A DIFFERENT LATERAL SACRAL ARTERY RADICULAR BRANCH. A MARATHON MICROCATHETER (EV3 INC.) WAS NAVIGATED AND POSITIONED 10 MM FROM THE FISTULOUS POINT. DMSO AND ONYX-18 (1.5 ML) WERE INJECTED UNTIL THERE WAS FILLING OF THE ENTIRE WIDTH OF THE DRAINING VEIN WITH ONYX. TWO MONTHS AFTER THE ORIGINAL EMBOLIZATION (2 WEEKS AFTER RE-EMBOLIZATION) THERE WAS IMPROVEMENT OF MOTOR FUNCTION WITH 4 TO 4+/5 STRENGTH IN ALL MUSCLE GROUPS. THE PATIENT WAS ABLE TO WALK INDEPENDENTLY OVER 250 FEET AT A TIME, AND THE PAIN HAD IMPROVED TO AN INTENSITY OF 3/10. URINARY AND BOWEL DYSFUNCTION WERE UNCHANGED. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -RESIDUAL FISTULA REQUIRING RE-EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481342 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention