BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 20472686 · Received October 17, 2024

    Report

    Report Number
    2029214-2024-01916
    Event Type
    Injury
    Date Received
    October 17, 2024
    Date of Event
    September 10, 2023
    Report Date
    November 12, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: IAMPREECHAKUL, P., WANGTANAPHAT, K., CHUNTAROJ, S., WATTANASEN, Y., HANGSAPRUEK, S., LERTBUTSAYANUKUL, P., & SIRIWIMONMAS, S.. SPONTANEOUS COMPLETE REGRESSION OF MALIGNANT CAVERNOUS SINUS DURAL ARTERIOVENOUS FISTULA FOLLOWING PARTIAL TRANSARTERIAL EMBOLIZATION WITH LIQUID EMBOLIC MATERIAL: REPORT OF TWO CASES. SCIENTIFIC SCHOLAR LLC VOL. 14, P. 307 2023. DOI:10.25259/SNI_594_2023. 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 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    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

    LITERATURE WAS REVIEWED REGARDING SPONTANEOUS COMPLETE REGRESSION OF MALIGNANT CAVERNOUS SINUS DURAL ARTERIOVENOUS FISTULA FOLLOWING PARTIAL TRANSARTERIAL EMBOLIZATION WITH LIQUID EMBOLIC MATERIAL: REPORT OF TWO CASES. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX LIQUID EMBOLIC NO DEATHS OCCURRED IN THE STUDY POPULATION. AMONG PATIENT ADVERSE EVENTS INCLUDED: TRANSARTERIAL EMBOLIZATION WITH ONYX THROUGH THE RIGHT ACCESSORY MENINGEAL ARTERY WAS PERFORMED WITH SOME PART OF ONYX FILLING INTO THE CAVERNOUS SINUS (CS). CONTROL ANGIOGRAPHY AFTER EMBOLIZATION DEMONSTRATED INCOMPLETE OBLITERATION OF THE FISTULA. ANOTHER SESSION OF EMBOLIZATION WAS SCHEDULED, AND CEREBRAL ANGIOGRAPHY OBTAINED 4 MONTHS LATER REVEALED COMPLETE REGRESSION OF THE FISTULA. AT THE 2-YEAR FOLLOW-UP, THE PATIENT REMAINED CLINICALLY ASYMPTOMATIC. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTHCARE PROVIDER (HCP) CONFIRMED THAT ONE OF THE LIQUID EMBOLIC MATERIALS USED IN THE SECOND CASE DESCRIBED IN THE ARTICLE WAS ONYX, A MEDTRONIC PRODUCT. THERE WERE NO ADVERSE EVENTS RELATED TO THE USE OF ONYX IN THIS CASE. IN FACT, THE HCP BELIEVED THAT ONYX PLAYED A CRUCIAL ROLE IN ACHIEVING A SUCCESSFUL OUTCOME FOR THIS VERY COMPLEX CASE. THE PRODUCT¿S PROPERTIES, SUCH AS SLOW POLYMERIZATION AND NON-ADHESIVE CHARACTERISTICS, WERE INSTRUMENTAL IN ALLOWING CONTROLLED EMBOLIZATION, WHICH CONTRIBUTED TO THE SPONTANEOUS REGRESSION OF THE DURAL ARTERIOVENOUS FISTULA (DAVF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288217 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention