BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX

    MDR report key: 17328719 · Received July 14, 2023

    Report

    Report Number
    2029214-2023-01115
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    October 31, 2022
    Report Date
    September 15, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: KOJIMA, D., AKAMATSU, Y., FUJIMOTO, K., OIKAWA, K., KASHIMURA, H., KUBO, Y., OGASAWARA, K.. UTILITY OF MANUAL VENOUS COMPRESSION DURING TRANSVENOUS ONYX INJECTION FOR A SCALP ARTERIOVENOUS FISTULA: ILLUSTRATIVE CASE. JOURNAL OF NEUROSURGERY. CASE LESSONS 2022;4(18). DOI:10.3171/CASE22317. 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN CHECKED WITH THE LOT NUMBERS: ONYX:TOTAL 5 B022794 B040351 B040352 ×2 A985332 MARATHON:1 B063606.

    Description of Event or Problem · 0

    KOJIMA D, AKAMATSU Y, FUJIMOTO K, ET AL. UTILITY OF MANUAL VENOUS COMPRESSION DURING TRANSVENOUS ONYX INJECTION FOR A SCALP ARTERIOVENOUS FISTULA: ILLUSTRATIVE CASE. JOURNAL OF NEUROSURGERY CASE LESSONS. 2022;4(18). DOI:10.3171/CASE22317. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX LIQUID EMBOLIC. THE PURPOSE OF THIS ARTICLE WAS TO DEMONSTRATE A SALVAGE TECHNIQUE TO ACHIEVE EFFECTIVE ONYX PENETRATION WITH MANUAL VENOUS COMPRESSION DURING TRANSVENOUS EMBOLIZATION. AFTER SUCCESSFUL TRANSARTERIAL OBLITERATION OF ONE ARTERIOVENOUS FISTULA (AVF), TRANSVENOUS ONYX EMBOLIZATION WAS PERFORMED FOR ANOTHER AVF LOCATED IN THE SUBCUTANEOUS LAYER. TO AVOID UNNECESSARY ONYX MIGRATION INTO MULTIPLE VENOUS NETWORKS, SEVERAL COILS WERE PUT IN A VENOUS POUCH AS A SCAFFOLD FOR THE ONYX, AND FEEDING ARTERIES WERE TEMPORARILY OCCLUDED. ONYX 18 WAS CONTINUOUSLY INJECTED FROM THE MARATHON CATHETER. DESPITE THESE ADJUNCTIVE TECHNIQUES, THE ONYX MIGRATED INTO MULTIPLE VEINS AND EVEN TOWARD THE ORBIT WITHOUT COMPLETE FISTULA OBLITERATION. THEREAFTER, ONYX WAS INJECTED UNDER MANUAL COMPRESSION OF VENOUS OUTLETS FROM THE POUCH, RESULTING IN COMPLETE OBLITERATION. THE PATIENT¿S POSTOPERATIVE COURSE WAS UNEVENTFUL, WITHOUT COSMETIC COMPLICATIONS AFFECTING THE SKIN. THE PATIENT HAS BEEN FREE FROM SYMPTOMS FOR 2 YEARS AFTER THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195771 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male