BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX AVM

    MDR report key: 11824019 · Received May 14, 2021

    Report

    Report Number
    2029214-2021-00572
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    May 5, 2021
    Report Date
    August 7, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    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

    H3. PRODUCT ANALYSIS FINDINGS: THE ONYX AND DMSO APPEARED TO HAVE BEEN USED AND EMPTY. ONYX RESIDUE WAS FOUND INSIDE OF THE ONYX VIAL. THE ONYX AND DMSO WERE NOT RETURNED AS THEY WERE CONSUMED IN THE EVENT. NO DAMAGES WERE FOUND WITH THE RETURNED VIALS. BASED ON ANALYSIS FINDINGS, THE ONYX WAS NOT CONFIRMED TO HAVE "POOR VISUALIZATION" AS THE ONYX VIAL WAS RETURNED EMPTY. THE ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE CAUSE INCLUDES NOT SHAKING THE ONYX PER THE IFU AND/OR INTERRUPT THE ONYX INJECTION FOR LONGER THAN TWO MINUTES PRIOR TO RE-INJECTION. THE REVIEW OF LOT HISTORY RECORDS SHOWS THAT THE FINISHED DEVICE HAS MET ALL MANUFACTURING REQUIREMENTS AND SPECIFICATIONS DURING FINAL ASSEMBLY AND QUALITY INSPECTION. PER OUR IFU (INSTRUCTIONS FOR USE): ¿SHAKE ONYX AT LEAST 20 MINUTES ON AN ONYX MIXER AT A SETTING OF 8. CONTINUE MIXING UNTIL READY TO INJECT. FAILURE TO CONTINUOUSLY MIX ONYX FOR THE REQUIRED TIME MAY RESULT IN INADEQUATE SUSPENSION OF THE TANTALUM, RESULTING IN INADEQUATE FLUOROSCOPIC VISUALIZATION DURING DELIVERY. INJECT ONYX IMMEDIATELY AFTER MIXING. DO NOT INTERRUPT THE ONYX INJECTION FOR LONGER THAN TWO MINUTES PRIOR TO RE-INJECTION. IF ONYX INJECTION IS DELAYED, TANTALUM SETTLING CAN OCCUR WITHIN THE SYRINGE RESULTING IN POOR VISUALIZATION OF ONYX DURING INJECTION.¿ 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. 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 AVM WAS LEFT PARIETAL. THE WAITING TIME BETWEEN INJECTIONS WAS LESS THAN 2 MINUTES. THE INJECTIONS WERE CONTINUOUS. THE AMOUNT OF REFLUX COULD NOT BE DETERMINED DURING THE PROCEDURE AS THE ONYX COULD NOT BE ADEQUATELY VISUALIZED. THE DEAD SPACE OF THE DELIVERY CATHETER WAS FILLED WITH DMSO, IN THIS CASE IT WAS APOLLO WITH INTERFACE.

    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 THERE WAS POOR ONYX VISUALIZATION. THE PATIENT WAS UNDERGOING TREATMENT FOR A GRADE IV ARTERIOVENOUS MALFORMATION (AVM) IN AN ELOQUENT REGION. THE PATIENT'S VESSEL TOR TUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN THE ONYX WAS STARTED TO BE INJECTED THE PHYSICIAN COULD PRACTICALLY NOT BE SEEN ON ANGIOGRAPHY AS IT WAS A DVANCED. THE DOCTOR DECIDED TO STOP OUT OF CONCERN FOR POSSIBLE REFLUX TOWARDS NORMAL ARTERIES. A CT SCAN VERIFIED OCCLUSION TO THE AVM AND THEY OBTAINED A GOOD RESULT. THE ONYX SHAKER HAD BEEN SET TO VELOCITY 8, AND IT HAD BEEN SHAKEN FOR 3 HOURS. THE ONYX DID NOT SIT FOR MORE THAN 5 MINUTES PRIOR TO INJECTION, AND THE PHYSICIAN INJECTED THE ONYX IMMEDIATELY AFTER SHAKING. ANGIOGRAPHICRESULTS POST PROCEDURE SHOWED THAT THE EMBOLIZATION WAS ADEQUATE FOR THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. NO EXTENDED HOSPITALIZATION OR ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS WERE NEEDED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A NAVIEN 6 FR GUIDE CATHETER, MIRAGE GUIDEWIRE, AND APOLLO 1.5 MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723775 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-7000-060 A927445

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR