BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17591730 · Received August 21, 2023

    Report

    Report Number
    2029214-2023-01443
    Event Type
    Injury
    Date Received
    August 21, 2023
    Date of Event
    August 9, 2019
    Report Date
    October 2, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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.

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: YOSHIDA, K., SATO, S., INOUE, T., RYU, B., SHIMA, S., MOCHIZUKI, T., KUWAMOTO, K., OKADA, Y., NIIMI, Y. TRANSVENOUS EMBOLIZATION FOR CRANIOCERVICAL JUNCTION EPIDURAL ARTERIOVENOUS FISTULA WITH A PIAL FEEDER ANEURYSM. INTERVENTIONAL NEURORADIOLOGY: JOURNAL OF PERITHERAPEUTIC N 26(2):170-177 2020. DOI:10.1177/1591019919874571. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT OF THE ADVERSE EVENTS THAT WERE MENTIONED WITHIN THE ARTICLE, NONE OF THEM RELATE DIRECTLY TO MEDTRONIC DEVICES/PRODUCTS.

    Description of Event or Problem · 0

    YOSHIDA K, SATO S, INOUE T, ET AL. TRANSVENOUS EMBOLIZATION FOR CRANIOCERVICAL JUNCTION EPIDURAL ARTERIOVENOUS FISTULA WITH A PIAL F EEDER ANEURYSM. INTERVENTIONAL NEURORADIOLOGY: JOURNAL OF PERITHERAPEUTIC NEURORADIOLOGY, SURGICAL PROCEDURES AND RELATED NEUROSCIENCES. 2020;26(2):170-177. DOI:10.1177/1591019919874571. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX LIQUID EMBOLIC. THE PURPOSE OF THIS ARTICLE WAS TO PRESENT A CASE OF CRANIOCERVICAL JUNCTION (CCJ) EPIDURAL ARTERIOVENOUS FISTULA (AVF) WITH A PIAL FEEDER ANEURYSM THAT EXPERIENCED RECANALIZATION SECONDARY TO RECRUITMENT OF NEW SHUNT FLOW. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE ONYX. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED:  - TRANSARTERIAL COIL EMBOLIZATION OF THE RUPTURED ANEURYSM AND PARTIAL ONYX EMBOLIZATION OF THE SHUNT LED TO THROMBOSIS OF THE ANEURYSM. THE PATIENT WAS DISCHARGED HOME WITHOUT NEUROLOGICAL DEFICIT. HOWEVER, THREE YEARS LATER ANGIOGRAPHY SHOWED AN INCREASED SHUNT FLOW AND RECURRENCE OF THE ANEURYSM. TRANSVENOUS EMBOLIZATION OF THE SHUNT USING COILS AND ONYX YIELDED COMPLETE OBLITERATION OF THE SHUNT, THUS LEADING TO OCCLUSION OF THE ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364393 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention