BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX AVM

    MDR report key: 8729615 · Received June 24, 2019

    Report

    Report Number
    2029214-2019-00611
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    June 3, 2019
    Report Date
    September 15, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE ONYX VIAL WAS RETURNED INSIDE OF A BIOHAZARD BAG AND A SHIPPING BOX. THE ONYX VIAL WAS USED AND EMPTY. ONYX RESIDUE WAS FOUND INSIDE OF THE VIAL. THE ONYX WAS NOT RETURNED AS IT WAS CONSUMED IN THE PATIENT. THE LOT HISTORY RECORD OF THE REPORTED LOT NUMBER A760245 REVEALED ONYX 18 SUBASSEMBLY PART NUMBER 50067-060 LOT A730547. FOR FURTHER INVESTIGATION, ONE ONYX VIAL FROM THE SAME LOT (A730547) WAS REQUESTED FROM QC RETAINED SAMPLES FOR TESTING. THE RETAINED ONYX VIAL WAS THEN PLACED ON AN IN-HOUSE ONYX MIXER AND THEN SHOOK FOR 20 MINUTES A SETTING OF 8 PER THE IFU. THE ONYX SOLUTION IN THE VIAL APPEARED TO BE MIXING WELL. AFTER MIXING, THE ONYX SOLUTION WAS THEN ASPIRATED IMMEDIATELY INTO AN IN-HOUSE ONYX 1ML SYRINGE WITH AN 18 GAUGE NEEDLE FOR DENSITY TESTING PER TM0027 REV. K. THE DENSITY MEASUREMENT FOR LOT: A730547= 1.72G/ML; WHICH IS WITHIN THE SPECIFICATIONS (1.71 +/- 0.1 G/ML). NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE ANALYSIS FINDINGS AND THE REPORTED EVENT DETAILS, THE CUSTOMER'S REPORT OF ¿POOR ONYX VISUALIZATION¿ WAS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED AS THE ONYX SOLUTION WAS NOT RETURNED. THE CUSTOMER REPORTED THAT "PRIOR TO THE PROCEDURE, THE ONYX WAS SHAKEN FOR MORE THAN 20 MINUTES ON AN ONYX SHAKER AT SPEED SETTING 8. THE ONYX DID NOT SIT FOR MORE THAN 5 MINUTES PRIOR TO INJECTION; THE ONYX WAS REPORTEDLY INJECTED IMMEDIATELY AFTER MIXING. THE ECHELON CATHETER WAS PRIMED WITH DMSO PER THE IFU." THE IN-HOUSE RETAINED ONYX VIAL WITH THE SAME LOT NUMBER WAS VISUALLY INSPECTED, MIXED AND THEN TESTED FOR DENSITY; AND FOUND TO BE WITHIN SPECIFICATIONS. THE LOT HISTORY RECORD OF THE TANTALUM POWDER'S LOT NUMBER HAS BEEN REVIEWED AND NO QUALITY ISSUES WERE NOTED. IN ADDITION, THE REVIEW OF LOT HISTORY RECORDS SHOWS THAT THE FINISHED DEVICE HAS MET ALL MANUFACTURING REQUIREMENTS AND SPECIFICATIONS DURING FINAL ASSEMBLY AND QUALITY INSPECTION. THERE WAS NO NON-CONFORMANCE TO SPECIFICATION IDENTIFIED THAT LED TO THE REPORTED ISSUE. . PER OUR INSTRUCTIONS FOR USE (IFU): ¿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. 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. 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 · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. SINCE THE DEVICE WAS NOT RETURNED, WE ARE UNABLE TO PERFORM FURTHER ROOT CAUSE ANALYSIS. ALL DEVICES ARE 100% TESTED AND ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO ONYX INJECTION TO OCCLUDE THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA), THE ECHELON MICROCATHETER WAS PRIMED WITH DMSO AS PER INSTRUCTIONS FOR USE (IFU). DURING THE ONYX INJECTION UNDER FLUOROSCOPY, THE ONYX COULD NOT BE SEEN AND THE PATIENT'S PARENT VESSEL (VERTEBRAL ARTERY) WAS OCCLUDED. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR PICA VESSEL. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. THERE WAS NO PATIENT SYMPTOM OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO IMAGES AVAILABLE FOR REVIEW. THE SPEED SETTING ON THE SHAKER WAS 8. MORE THAN 20 MINS THE ONYX SHAKEN. THE ONYX VIALS DID NOT SIT MORE THAN 5 MINUTES PRIOR TO INJECTION. THE PHYSICIAN INJECT THE ONYX IMMEDIATELY AFTER MIXING. THE PHYSICIAN DID USE A CONTINUOUS INJECTION DURING THE PROCEDURE. THE INJECTION RATE WAS DONE AS INDICATED PER THE IFU. THEY PROCEED TO COIL OFF THE VA SECTION TO FULLY OCCLUDE IT. PATIENT¿S CONDITION WAS STABLE AFTER THE PROCEDURE AS OF (B)(6) 2019 BUT PASSED AWAY WHEN THE REP CHECKED IN ON (B)(6) 2019. THE EXACT DATE OF DEATH WAS NOT DISCLOSED BY THE TREATING FACILITY. THE ANGIOGRAPHIC RESULT SHOWED THE RIGHT PICA AND VA WERE OCCLUDED. GE BIPLANE EQUIPMENT WAS USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521654 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-7000-060 A760245

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability