BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 17316212 · Received July 13, 2023

    Report

    Report Number
    2029214-2023-01107
    Event Type
    Death
    Date Received
    July 13, 2023
    Date of Event
    July 14, 2022
    Report Date
    October 4, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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.

    Additional Manufacturer Narrative · 0

    B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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

    FIFI, J. T., BAZIL, M. J., MATSOUKAS, S., SHIGEMATSU, T., SORSCHER, M., BERENSTEIN, A. EVOLUTION OF TRANSVENOUS EMBOLIZATION IN VEIN OF GALEN MALFORMATION: CASE SERIES AND REVIEW OF THE LITERATURE. NEUROINTERVENT SURG. 2023; 15:579¿583. 2023. DOI: 10.1136/JNIS-2022- 019121. SUMMARY: TREATMENT OF VEIN OF GALEN MALFORMATIONS (VOGMS) HAS IMPROVED GREATLY SINCE THE INCEPTION OF ENDOVASCULAR TREATMENT. TRANSVENOUS EMBOLIZATION (TVE) IS AN ATTRACTIVE OPTION TO ACHIEVE COMPLETE OBLITERATION. TO REVIEW THE LITERATURE ON TVE OF VOGM AND THEN ANALYZE OUR PRACTICE¿S UNIQUE EXPERIENCE AND EVOLVING TREATMENT STRATEGIES OVER 30 YEARS. METHODS A RETROSPECTIVE REVIEW OF OUR CLINICAL DATABASE FOR PATIENTS WITH THE DIAGNOSIS OF VOGM TREATED BETWEEN JANUARY 2004 AND AUGUST 2021 WAS PERFORMED. A LITERATURE REVIEW OF 49 RELEVANT ARTICLES WAS ALSO CARRIED OUT. TVE IN VOGM HAS EVOLVED WITH INITIAL INTRODUCTION AS A TRANSTORCULAR (TT) APPROACH, WHICH THEN LOST FAVOR TO TRANSARTERIAL EMBOLIZATION (TAE). TAE HAS BEEN CONSIDERED THE MORE FAVORABLE APPROACH IN MOST HIGH-VOLUME CENTERS. IN MORE RECENT TIMES, THE TRANSVENOUS EMBOLIZATION (TVE) APPROACH HAS BEEN REVISITED AS A LAST TREATMENT TO ACHIEVE A CURE AFTER A SERIES OF TAE TREATMENTS. WE PRESENTLY FAVOR BEGINNING TREATMENT WITH STAGED TAE TO REDUCE FLOW TO THE LESION AND, IMPORTANTLY, SHRINK THE DRAINING VEIN. THIS THEN ALLOWS FOR THE PERFORMANCE OF TVE WITH THE CHAPOT PRESSURE COOKER TECHNIQUE (CPCT) WITH COILS AND LIQUID EMBOLIC EMBOLIZATION. TT TVE ITSELF CARRIES A HIGH DEGREE OF RISK AND IS MOST HIGHLY ASSOCIATED WITH LONG-TERM MORBIDITIES AND MORTALITY. TRADITIONAL TRANSFEMORAL/TRANSJUGULAR TVE APPROACHES ARE SAFE AND EFFECTIVE IN SIMPLE FISTULAS WITH A SMALL VENOUS POUCH; HOWEVER, WE BELIEVE THAT THE CPCT IS THE SAFEST TECHNIQUE AS A LAST-STAGE TREATMENT FOR ITS SECURITY IN AVOIDING REFLUX AND OBTAINING OCCLUSION OF THE SMALL PERFORATORS. REPORTED EVENTS: THE PATIENTS TREATED WITH TRANSFEMORAL TVE VIA COILS DISPLAYED ONLY AN 80% (8/10) FAVORABLE OUTCOME WITHOUT PERMANENT COMPLICATIONS, 20% (2/10) HAD A BAD OUTCOME OF HEMORRHAGE, RESULTING IN ONE PERMANENT COMPLICATION (FIGURE 1) AND ONE MORTALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171126 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death