BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX

    MDR report key: 12674991 · Received October 21, 2021

    Report

    Report Number
    2029214-2021-01322
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    June 2, 2021
    Report Date
    November 24, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS NO LONGER A REPORTABLE EVENT AND DOES NOT MEET THE DEFINITION OF A COMPLAINT. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL MDRS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED MAKES THE EVENT REPORTABLE. DUE TO GCH FUNCTIONALITY, THE COMPLAINT FLAG CANNOT BE FLIPPED TO 'NO' AS A REGULATORY REPORT ALREADY EXISTS. 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 COREL LAB AND PI HAVE RE-REVIEWED THE IMAGES AND CONFIRMED THAT THERE WAS NO REFLUX TO THE NON-TARGET VESSEL DURING MMA EMBOLIZATION. THEREFORE, THE EVENT NO LONGER MEETS THE DEFINITION OF A COMPLAINT. THIS EVENT IS NO LONGER A REPORTABLE EVENT. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL MDRS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED MAKES THE EVENT REPORTABLE. DUE TO GCH FUNCTIONALITY, THE COMPLAINT FLAG CANNOT BE FLIPPED TO 'NO' AS A REGULATORY REPORT ALREADY EXISTS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REPORTING THAT DURING AN PRE-MARKET STUDY PROCEDURE FOR ONYX EMBOLIZATION IN THE MIDDLE MENINGEAL ARTERY (MMA), IMAGING CORE LAB NOTED PRESENCE OF REFLUX TO NON-TARGET VESSEL. NO PATIENT INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573105 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX B177502

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male