BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17509139 · Received August 11, 2023

    Report

    Report Number
    2029214-2023-01352
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    January 1, 2008
    Report Date
    August 11, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFER TO REGULATORY REP#: 2029214-2023-01351 FOR RELATED EVENT INFORMATION. MARCELIN C, LE BRAS Y, PETITPIERRE F, MIDY D, DUCASSE E, GRENIER N, CORNELIUS F. SAFETY AND EFFICACY OF EMBOLIZATION USING ONYX® OF PERSISTENT TYPE II ENDOLEAKS AFTER ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR. INTERVENTIONAL IMAGING (2017). 98, 491-497. DOI: 10.1016 /J.DIII.2017.01.003 2211-5684. A2 75 YEARS IS THE AVERAGE AGE OF THE PATIENTS WHO PARTICIPATED IN THE STUDY. A3 MALE IS A MAJORITY OF THE PATIENTS WHO PARTICIPATED IN THE STUDY. 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.

    Description of Event or Problem · 0

    THE PURPOSE OF THE ARTICLE WAS TO RETROSPECTIVELY EVALUATE THE SAFETY AND EFFICACY OF EMBOLIZATION OF PERSISTENT TYPE II ENDOLEAKS OCCURRING AFTER ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) USING ETHYLENE VINYL ALCOHOL COPOLYMER (ONYX®). MATERIAL AND METHODS: BETWEEN 2008 AND 2016, 28 CONSECUTIVE'S PATIENTS (25 MEN, 3 WOMEN) WITH A MEAN AGE OF 75.3 YEARS ± 9 (SD) (RANGE: 59¿90 YEARS) WERE TREATED FOR 29 PERSISTENT TYPE II ENDOLEAKS WITH INCREASING ANEURYSM SIZE > 5 MM OCCURRING AFTER EVAR. A TOTAL OF 35 EMBOLIZATION PROCEDURES WERE PERFORMED USING ONYX®, VIA A TRANSARTERIAL ROUTE (N = 25) OR DIRECT PUNCTURE (N = 10), WITH OR WITHOUT ADDITIONAL METALLIC COILS. THE ENDPOINTS WERE TO EVALUATE THE CLINICAL EFFICACY, CORRESPONDING TO THE STABILIZATION OR DECREASE OF ANEURISM SIZE, AND THE TECHNICAL EFFICACY, CORRESPONDING TO THE ABILITY TO COMPLETE THE EMBOLIZATION. RESULTS: NO SEVERE COMPLICATIONS WERE OBSERVED DURING AND AFTER EMBOLIZATION. THE PRIMARY AND SECONDARY CLINICAL EFFICACIES WERE 75% (21/28) AND 96.4% (27/28), RESPECTIVELY. OVERALL PRIMARY TECHNICAL EFFICACY RATE WAS 58.6% (17/29), GREATER FOR TRANSARTERIAL TECHNIQUE (72.8%) THAN FOR DIRECT PUNCTURE (14.3%) (P = 0.01). SECONDARY TECHNICAL EFFICACY WAS 72.4% (21/29), WITH NO DIFFERENCES BETWEEN TRANSARTERIAL (81.8%) AND DIRECT PUNCTURE (42.8%) (P = 0.06).   THE PRIMARY CLINICAL EFFICACY RATE ON A PER PATIENT BASIS WAS 75% (21/28). A CLINICAL FAILURE WAS OBSERVED IN 7/28 PATIENTS (25%) AT THE TIME OF THE FIRST EVALUATION AFTER EMBOLIZATION. THE REASONS DETECTED WERE 6 PERSISTENT TYPE II ENDOLEAKS AND ONE NEW TYPE II ENDOLEAK. ADDITIONAL EMBOLIZATION PROCEDURES WERE PERFORMED IN 6/28 PATIENTS (21.4%) WITH PERSISTENT ENDOLEAKS, SUCCESSFULLY IN 5 PATIENTS AFTER ONE (N = 4) OR TWO SESSIONS (N = 1). AT THE DATE OF LAST FOLLOW-UP, ANEURYSM DIAMETER DECREASED IN 5/28 PATIENTS (17.8%) WITH A MEAN DECREASE OF 13.7 MM (RANGE: 6¿22 MM). ANEURYSM DIAMETER REMAINED STABLE IN 22/28 PATIENTS (78%) AND INCREASED OF 11 MM IN 1/28 PATIENT (3.5%). SECONDARY CLINICAL EFFICACY WAS 96.4% (27/28). AFTER EMBOLIZATION OF THE 29 TYPE II ENDOLEAKS, THE OVERALL PRIMARY AND SECONDARY TECHNICAL EFFICACY RATES WERE 58.6% (17/29), AND 72.4% (21/29), RESPECTIVELY. PRIMARY TECHNICAL EFFICACY WAS GREATER WITH TRANSARTERIAL TECHNIQUE (72.8%) THAN WITH DIRECT PUNCTURE (14.3%)  AND WHEN THE EMBOLIZATION WAS COMPLETE (100%) THAN INCOMPLETE (29.4%) OR WHEN ITS ORIGIN WAS THE IMA. SECONDARY TECHNICAL EFFICACY WAS GREATER WHEN THE EMBOLIZATION WAS COMPLETE (100%) THAN INCOMPLETE (52.9%). DURING THE FOLLOW-UP, THREE TYPE I ENDOLEAKS WERE TREATED (2 USING ENDOVASCULAR TREATMENTS AND 1 WITH A COMBINED TREATMENT WITH ENDOVASCULAR AND EMBOLIZATION) 10 MONTHS AFTER EMBOLIZATION (RANGE: 9¿12 MONTHS), AND ONE TYPE III ENDOLEAK (36 MONTHS AFTER THE EMBOLIZATION) WAS TREATED BY EXTENSION OF EVAR. PATIENTS WITH TYPE I AND TYPE III ENDOLEAKS HAD A STABLE ANEURYSM SIZE AFTER A MEAN FOLLOW-UP OF 11.5 MONTHS (RANGE: 4¿19 MONTHS).   CONCLUSION: EMBOLIZATION WITH ONYX® OF TYPE II ENDOLEAKS AFTER EVAR APPEARS A SAFE AND EFFECTIVE PROCEDURE.   ADVERSE EVENTS INCLUDED: 1. ENDOLEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783556 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other