BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 17556400 · Received August 16, 2023

    Report

    Report Number
    2029214-2023-01403
    Event Type
    Death
    Date Received
    August 16, 2023
    Date of Event
    December 12, 2022
    Report Date
    August 16, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEE ATTACHMENTS FOR LITERATURE ARTICLE. 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

    XINNI XU, ANIL GOPINATHAN, YEW KWANG ONG, MARK KIM THYE THONG, WOEI SHYANG LOH, KWOK SENG LOH; HEAD & NECK; 2023: 45(6):1604-1614; DECONSTRUCTIVE VERSUS RECONSTRUCTIVE APPROACH TO INTERNAL CAROTID ARTERY BLOWOUT IN RADIATED NASOPHARYNGEAL CARCINOMA: A TERTIARY CENTER EXPERIENCE AND SYSTEMATIC REVIEW; DOI:10.1002/HED.27367. MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE OF PATIENT'S TREATED WITH ONYX EMBOLIZATION OR PIPELINE STENTS HAVING COMPLICATIONS. THE OBJECTIVE OF THIS STUDY WAS TO COMPARE THE OUTCOMES OF PARENT ARTERY OCCLUSION (PAO) VERSUS STENT-ASSISTED RECONSTRUCTION IN RADIATED NASOPHARYNGEAL CARCINOMA (NPC) PATIENTS WITH INTERNAL CAROTID ARTERY (ICA) BLOWOUTS. A RETROSPECTIVE REVIEW FROM THE STUDY INSTITUTION (2011¿2021) AND SYSTEMATIC REVIEW OF PUBMED AND EMBASE (1995¿2022) WAS PERFORMED. EIGHTY-SIX PAOS AND 37 STENT-ASSISTED RECONSTRUCTIONS WERE ANALYZED, INCLUDING 11 PAOS AND 5 STENTS FROM OUR INSTITUTION. RETROSPECTIVE REVIEW PROCEDURE: ALL ENDOVASCULAR INTERVENTIONS WERE PERFORMED UNDER GENERAL ANESTHESIA THROUGH TRANSFEMORAL ACCESS BY CREDENTIALED NEUROINTERVENTIONAL RADIOLOGISTS, ACCORDING TO A PREVIOUSLY PUBLISHED PROTOCOL. THE SITE OF THE PSEUDOANEURYSM AND BACKGROUND STATUS OF THE ARTERIES WERE EVALUATED. CROSS-CIRCULATION THROUGH THE CIRCLE OF WILLIS WAS EVALUATED WITH EITHER A BALLOON TEST OCCLUSION (BTO) OR MANUAL CAROTID COMPRESSION USING THE MATAS AND ALLCOCK MANEUVERS TO ASSESS THE CONTRALATERAL ICA AND VERTEBRAL ARTERIES, RESPECTIVELY. PAO WAS THE TREATMENT OF CHOICE IF THE PATIENT QUALIFIED THE ANGIOGRAPHIC TEST OCCLUSION; OTHERWISE STENT-ASSISTED RECONSTRUCTION WAS ATTEMPTED USING FLOW DIVERTER STENTS. PAO WAS PERFORMED BY SEGMENTAL OCCLUSION OF THE INVOLVED SEGMENT WITH COILS. VASCULAR PLUGS WERE USED PROXIMALLY IN SOME CASES. FOR PATIENTS WHO UNDERWENT STENTING, FOLLOW-UP DSAS OR COMPUTED TOMOGRAPHY ANGIOGRAPHIES WERE PERFORMED IN THE SUBSEQUENT WEEKS TO MONTHS TO ASSESS RESPONSE. DUAL ANTIPLATELETS WITH ASPIRIN 100 MG AND P2Y12 RECEPTOR BLOCKERS (CLOPIDOGREL 75 MG OR TICAGRELOR 90/60 MG BD) WERE INITIATED IN THE PERI-PROCEDURAL PERIOD. ASPIRIN WAS CONTINUED FOR LIFE WHILE THE DURATION OF P2Y12 INHIBITORS WAS MODULATED ON A CASE-BY-CASE BASIS. RETROSPECTIVE REVIEW RESULTS: FIVE PATIENTS (31.3%) FAILED THE TEMPORARY OCCLUSION TESTS AND UNDERWENT ENDOVASCULAR RECONSTRUCTION WITH PIPELINE FLEX/SHIELD EMBOLIZATION DEVICE. ADJUNCTIVE COILS WERE USED IN FOUR PATIENTS AND ONE PATIENT RECEIVED BOTH COILS AND ONYX. A MEAN OF 2.2 FLOW DIVERTER STENTS WERE DEPLOYED PER PATIENT AT THE FIRST INTERVENTION. POST-PROCEDURE, THREE PATIENTS DEVELOPED STROKE (TWO WITH PERMANENT HEMIPARESIS, ONE WITH FULL FUNCTIONAL RECOVERY) AND ONE PATIENT HAD BLEEDING FROM THE RECURRENT TUMOR. THREE PATIENTS (60%) HAD COMPLETE OCCLUSION OF THE PSEUDOANEURYSM WITHIN 3 MONTHS OF TREATMENT. IN THE REMAINING TWO PATIENTS, THEIR PSEUDOANEURYSMS CONTINUED TO ENLARGE ON FOLLOW-UP ANGIOGRAMS. ONE OF THEM UNDERWENT ADDITIONAL DEPLOYMENT OF TWO OVERLAPPING SURPASS EVOLVE FLOW DIVERTERS AND THE OTHER UNDERWENT ECA-ICA BYPASS WITH CAROTID LIGATION. BOTH DEMISED IN THE SUBSEQUENT FEW WEEKS. NONE OF OUR PATIENTS HAD STENT THROMBOSIS. SYSTEMATIC REVIEW: A TOTAL OF 123 RADIATED NPC PATIENTS (MEAN AGE 57.6, SD 11.3 YEARS) WITH ICA BLOWOUTS WERE ANALYZED, INCLUDING THE 16 PATIENTS FROM THE STUDY INSTITUTION. IN THE STENT GROUP, MAJORITY OF THE STENTS USED WERE PIPELINE EMBOLIZATION DEVICES (FLOW DIVERTER STENTS) (60.3%, 35/58) FOLLOWED BY COVERED STENTS (31.0%, 18/58). EACH PATIENT REQUIRED AN AVERAGE OF 1.6 STENTS. IN 3 STUDIES, THE STENTS WERE SUPPLEMENTED BY COILS TO THE PSEUDOANEURYSM SAC AND IN 1 STUDY, A LIQUID MIXTURE OF 20% N-BUTYL-CYANOACRYLATE GLUE AND 80% LIPIODOL OIL WAS USED TO SEAL BLEEDING SITES AND ENDOLEAKS AFTER DEPLOYING THE STENTS. POSTSTENTING ANTIPLATELETS WAS ADMINISTERED IN ALL STUDIES EXCEPT FOR ONE. SYSTEMATIC REVIEW OUTCOME: STENT RECONSTRUCTION WAS ASSOCIATED WITH A SIGNIFICANTLY HIGHER INCIDENCE OF OVERALL RE-BLEEDING, DELAYED STROKE, AND ALL-CAUSE DEATH COMPARED TO PAO. THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE PAO AND STENTS WITH REGARDS TO EARLY OR LATE RE-BLEEDING, OVERALL OR EARLY STROKE, INFECTION, EXTRUDED/MIGRATED FOREIGN BODY, AND PERI-PROCEDURE DEATH. AMONG THOSE IN THE STENT GROUP WHO UNDERWENT FOLLOW-UP ANGIOGRAMS, THE POOLED PROPORTION OF ENLARGING PSEUDOANEURYSMS WAS 11.1% AND THAT OF RESIDUAL, ASYMPTOMATIC PSEUDOANEURYSMS WAS 7.4%. THE POOLED PROPORTION OF STENT OCCLUSION WAS 40.0%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410284 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death