BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX AVM

    MDR report key: 12017457 · Received June 17, 2021

    Report

    Report Number
    2029214-2021-00742
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    June 1, 2021
    Report Date
    July 15, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS NO ONYX REFLUX, AND THE DEAD SPACE OF THE DELIVERY CATHETER HAD BEEN FILLED WITH DMSO DURING PREPARATION.

    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 A REPORT THAT MIXING OF THE ONYX DID NOT SEEM TO HAVE BEEN DONE PROPERLY AS IT WAS BLURRED IN THE ANGIOGRAPH WHEN INJECTED, AND SEEMED WATERY. THE PHYSICIAN WONDERED IF THE CONCENTRATION OF TANTALUM WAS TOO LITTLE. THE PATIENT WAS UNDERGOING TREATMENT OF A SEVERE ARTERIOVENOUS MALFORMATION IN AN ELOQUENT REGION, WITH A SEVERE VESSEL TORTUOSITY. THE ONYX WAS MIXED ACCORDING TO THE IFU AT INTENSITY 8 FOR 1 HOUR. THE ONYX VIALS SAT MORE THAN 5 MINUTES PRIOR TO INJECTION, AND THE PHYSICIAN DID NOT RE-SHAKE THE VIALS. THE PHYSICIAN DID NOT HEAT, SHAKE, OR RE-HEAT THE ONYX VIALS PRIOR TO ASPIRATION. INJECTION WAS PERFORMED IMMEDIATELY AFTER MIXING. THERE WERE NO RELATED PATIENT SYMPTOMS AND POST PROCEDURE ANGIOGRAPHIC RESULTS WERE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917411 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-7000-060 B172056

    Patients

    Seq Age Sex Outcome Treatment
    1