BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX

    MDR report key: 17450070 · Received August 3, 2023

    Report

    Report Number
    2029214-2023-01278
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    February 12, 2015
    Report Date
    August 31, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. SEE ATTACHED LITERATURE ARTICLE NO SPECIFIC DEVICE INFORMATION PROVIDED 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 WAS RECEIVED THAT THE EVENT WAS NOT RELATED TO THE MEDTRONIC DEVICE.

    Description of Event or Problem · 0

    ALARAJ, A., AMIN-HANJANI, S., SHAKUR, S. F., ALETICH, V. A., IVANOV, A., CARLSON, A. P., OH, G., CHARBEL, F. T. QUANTITATIVE ASSESSMENT OF CHANGES IN CEREBRAL ARTERIOVENOUS MALFORMATION HEMODYNAMICS AFTER EMBOLIZATION. STROKE. 2015. 46:942-947. DOI: 10.1161/STROKE AHA.114.008569 SUMMARY: EMBOLIZATION REDUCES FLOW IN ARTERIOVENOUS MALFORMATIONS (AVMS) BEFORE SURGICAL RESECTION, BUT ACHIEVEMENT OF THIS GOAL IS DETERMINED SUBJECTIVELY FROM ANGIOGRAMS. HERE, WE QUANTIFY EFFECTS OF EMBOLIZATION ON AVM FLOW. METHODS¿RECORDS OF PATIENTS WHO UNDERWENT AVM EMBOLIZATION AT OUR INSTITUTION BETWEEN 2007 AND 2013 AND HAD FLOW RATES OBTAINED PRE- AND POSTEMBOLIZATION USING QUANTITATIVE MAGNETIC RESONANCE ANGIOGRAPHY WERE RETROSPECTIVELY REVIEWED. TOTAL FLOW WAS ESTIMATED AS AGGREGATE FLOW WITHIN PRIMARY ARTERIAL FEEDERS OR FLOW IN SINGLE DRAINING VEINS. TWENTY-ONE PATIENTS WERE INCLUDED (MEAN AGE 35 YEARS, 24% HEMORRHAGIC PRESENTATION) WITH SPETZLER¿MARTIN GRADES 1 TO 4. FIFTY-FOUR TOTAL EMBOLIZATION SESSIONS WERE PERFORMED. THE MEAN AVM FLOW WAS 403.4±262.4 ML/MIN AT BASELINE, 285.3±246.4 ML/MIN AFTER SINGLE SESSION (29% DROP, P <(><<)>0.001), AND 102.0±103.3 ML/MIN AFTER ALL SESSIONS OF EMBOLIZATION (75% DROP, P<(><<)> 001). TOTAL NUMBER OF PEDICLES EMBOLIZED (P<(><<)> .001) AND EMBOLIZATION OF AN INTRANIDAL FISTULA DURING ANY SESSION (P=0.002) WERE SIGNIFICANTLY ASSOCIATED WITH TOTAL DECREASED FLOW POSTEMBOLIZATION. ON MULTIVARIATE ANALYSIS, TOTAL PEDICLES EMBOLIZED WAS PREDICTIVE OF TOTAL FLOW DROP (P<(><<)> 001). HOWEVER, PEDICLES EMBOLIZED PER SESSION DID NOT CORRELATE WITH FLOW DROP RELATED TO THAT SESSION (P=0.44). AVM FLOW CHANGES AFTER EMBOLIZATION CAN BE MEASURED USING QUANTITATIVE MAGNETIC RESONANCE ANGIOGRAPHY. THE TOTAL NUMBER OF PEDICLES EMBOLIZED AFTER MULTIPLE EMBOLIZATION SESSIONS WAS PREDICTIVE OF FINAL FLOW, INDICATING THIS PARAMETER IS THE BEST ANGIOGRAPHIC MARKER OF A HEMODYNAMICALLY SUCCESSFUL INTERVENTION. THE NUMBER OF PEDICLES EMBOLIZED PER SESSION, HOWEVER, DID NOT CORRELATE WITH FLOW DROP IN THAT SESSION, LIKELY BECAUSE OF FLOW REDISTRIBUTION AFTER PARTIAL EMBOLIZATION. REPORTED EVENTS: IN ONE PATIENT (PATIENT NUMBER 5), AVM FLOW DID NOT DROP BELOW BASELINE FLOW OVER 4 EMBOLIZATION SESSIONS BUT WAS REDISTRIBUTED. REVIEW OF THIS PATIENT¿S ANGIOGRAM AT THE COMPLETION OF ALL EMBOLIZATION SESSIONS DEMONSTRATED A SMALL AMOUNT OF ONYX MAINLY WITHIN FEEDER ARTERIES RATHER THAN IN THE NIDUS. THUS, THE FLOW WAS REDISTRIBUTED INTO THE NIDUS THROUGH COLLATERAL PIAL FEEDERS WITH MAINTENANCE OF THE SAME FLOW WITHIN THE AVM NIDUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325036 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown