BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 17287177 · Received July 10, 2023

    Report

    Report Number
    2029214-2023-01052
    Event Type
    Death
    Date Received
    July 10, 2023
    Date of Event
    December 4, 2022
    Report Date
    July 8, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ARTICLE IS FROM POLAND. 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

    MILOSZ PINKIEWICZ, MATEUSZ PINKIEWICZ, JERZY WALECKI, AND MICHAL ZAWADZKI; JOURNAL OF CLINICAL MEDICINE; 2022; 11, 7208; STATE OF THE ART IN THE ROLE OF ENDOVASCULAR EMBOLIZATION IN THE MANAGEMENT OF BRAIN ARTERIOVENOUS MALFORMATIONS¿A SYSTEMATIC REVIEW; DOI.ORG/1 0.3390/JCM11237208. MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE OF PATIENT TREATED WITH ONYX HAVING COMPLICATIONS INCLUDING DEATH. THE ARTICLE IS A SYSTEMATIC LITERATURE REVIEW THAT PROVIDES THE STATE OF THE ART IN ALL ASPECTS OF ENDOVASCULAR EMBOLIZATION IN THE MANAGEMENT OF BRAIN ARTERIOVENOUS MALFORMATIONS (BAVMS). AFTER EXCLUSIONS 118 ARTICLES WERE INCLUDED IN THE ANALYSIS. ACCORDING TO A SYSTEMATIC REVIEW, THE INCIDENCE OF BAVMS IS APPROXIMATELY 1 PER 100,000 PER YEAR IN UNSELECTED POPULATIONS, WITH THE POINT PREVALENCE IN ADULTS BEING EQUAL TO 18 CASES PER 100,000. IT HAS BEEN ESTIMATED THAT BAVMS ACCOUNT FOR 1¿2% OF ALL STROKES, 3% OF STROKES IN YOUNG ADULTS, 9% OF SUBARACHNOID HEMORRHAGES, AND 4% OF ALL PRIMARY INTRACRANIAL HEMORRHAGES. THESE BAVMS ARE RESPONSIBLE FOR 25% OF HEMORRHAGIC STROKES IN ADULTS BELOW THE AGE OF 50 YEARS. APPROXIMATELY 15% OF PEOPLE SUFFERING FROM BAVMS ARE ASYMPTOMATIC AT THE TIME OF DETECTION, WHEREAS AROUND 20% DEMONSTRATE SEIZURES, AND ABOUT TWO-THIRDS PRESENT AN INTRACRANIAL HEMORRHAGE.  THE REPORTED MORTALITY RATES IN BAVM PATIENTS RANGE FROM 0.7 TO 2.9% PER YEAR. OBSERVATIONAL STUDIES REPORTED THAT THE MORTALITY RATE AFTER INTRACRANIAL HEMORRHAGE FROM BAVMS RUPTURE RANGED FROM 12 TO 66.7%. ACCORDING TO A SYSTEMATIC REVIEW OF 18 STUDIES WITH A TOTAL OF 8418 BAVMS, THE AVERAGE ANNUALIZED HEMORRHAGE RATE WAS 2.2% FOR UNRUPTURED BAVMS AND 4.3% FOR BAVMS THAT PRESENTED WITH BLEEDING. TECHNIQUES: ENDOVASCULAR TREATMENT OF BAVMS BEGAN WITH THE APPLICATION OF N-BUTYL CYANOACRYLATE GLUE (NBCA) AND FLOW-DIRECTED MICROCATHETERS TO EMBOLIZE THE NIDUS. LIQUID EMBOLIC AGENTS (LEAS) ARE MOST COMMONLY USED; THANKS TO THEIR PROLONGED POLYMERIZATION TIMES, THEY ALLOW FOR A HOMOGENOUS FILLING OF THE VASCULAR AREA, THUS LIMITING THE RISK OF THE SECONDARY REOPENING OF THE EMBOLIZED AREA. CONTEMPORARY EMBOLIZATIONS OF BAVMS RELY ON NONADHESIVE COPOLYMERS SUCH AS ONYX AND PHIL DUE TO THEIR LOWER RISK OF CATHETER ENTRAPMENT AND LONGER POLYMERIZATION TIME, WHICH FACILITATE CONTROLLED INJECTIONS WITH DEEPER NIDAL PENETRATION. TO REDUCE THE RISK OF CATHETER ENTRAPMENT BY ONYX REFLUX, AN ARTICLE PROPOSED THE ¿REVERSE PLUG THEN PUSH¿ TECHNIQUE, WHICH ALLOWS FOR A MORE SWIFT INJECTION OF ONYX THANKS TO THE FORMATION OF A WELL-CONTROLLED PLUG PRIOR TO TREATMENT. THE AUTHORS OBTAINED A COMPLETE ANGIOGRAPHIC OBLITERATION IN 83% OF PATIENTS AFTER A SINGLE TREATMENT. THE AVERAGE BAVM VOLUME WAS 14.9 ML WITH A MEDIAN VOLUME OF 5.85 ML AND A LOWER AND UPPER QUARTILE OF 0.94 AND 12.5 ML, RESPECTIVELY. OF THE BAVMS, 50% HAD DEEP VENOUS DRAINAGE WHEREAS 75% INVOLVED ELOQUENT PORTIONS OF THE CORTEX. THE MORBIDITY AND MORTALITY WERE EACH 8%. TRADITIONALLY, THE PLUG-AND-PUSH TECHNIQUE HAS BEEN SUCCESSFULLY EMPLOYED TO OBLITERATE THE NIDUS. COMPLICATIONS: DEATH, PERMANENT MORBIDITY, PERMANENT NEUROLOGICAL DEFICIT, PERMANENT DEFICITS, AND OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699053 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death