BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 17778254 · Received September 19, 2023

    Report

    Report Number
    2029214-2023-01773
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    December 3, 2019
    Report Date
    September 19, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E: INITIAL REPORTER INFORMATION HAS BEEN CORRECTED. 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

    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

    ELENA SOLLI, FAREED JUMAH, VINAYAK NARAYAN, TRAVIS QUINOA, ZHENGGANG XIONG, GAURAV GUPTA, ENMAR ALHARFOUSH, ANIL NANDA; ACTA NEUROCHIRURGICA; 2020; 162:923¿928; RESECTION OF A POSTERIOR FOSSA ARTERIOVENOUS MALFORMATION COMPLICATED BY LEAKED ONYX: A CASE REPORT AND REVIEW OF LITERATURE; DOI.ORG/10.1007/S00701-019-04199-3 MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE THAT A PATIENT TREATED WITH ONYX HAD LEAKAGE OF ONYX INTO THE CEREBELLUM. THE PATIENT IS A 62-YEAR-OLD WOMAN WHO INITIALLY PRESENTED TO AN OUTSIDE HOSPITAL COMPLAINING OF SEVERE HEADACHE, NAUSEA, VOMITING, AND VISUAL DISTURBANCES. THE PATIENT UNDERWENT DIAGNOSTIC ANGIOGRAPHY WHICH SHOWED A 2.5-CM VERMIAN ARTERIOVENOUS MALFORMATION (AVM), AS WELL AS A RUPTURED 3-MM MID-LEFT T POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) ANEURYSM. THE ANEURYSM, WHICH WAS IDENTIFIED AS THE SOURCE OF HEMORRHAGE, WAS SUPPLIED MAINLY BY DISTAL BRANCHES OF THE LEFT PICA AND LEFT SUPERIOR CEREBELLAR ARTERY, WITH A SMALLER AMOUNT OF BLOOD SUPPLY COMING FROM DISTAL BRANCHES OF THE RIGHT PICA. PROCEDURE: AFTER VISUALIZATION OF THE AVM AND ANEURYSM ON ANGIOGRAM, EMBOLIZATION WAS PERFORMED. USING ROADMAP TECHNIQUE, A CAT 5 GUIDE CATHETER WITH A SCEPTER BALLOON AND SYNCHRO STANDARD WIRE WERE GUIDED INTO THE LEFT VERTEBRAL ARTERY. THE BALLOON AND WIRE WERE THEN MANEUVERED INTO THE MIDPORTION OF THE LEFT PICA. THE BALLOON WAS INFLATED PROXIMALLY TO THE RUPTURED LEFT PICA ANEURYSM. THE ANEURYSM AND DISTAL AVM WERE THEN EMBOLIZED USING ONYX 18. ONYX EXTRAVASATED FROM THE RUPTURED LEFT PICA ANEURYSM AND WAS SEEN ALONG THE SURFACE OF THE CEREBELLUM AND WITHIN THE FOURTH VENTRICLE. COMPLETE EMBOLIZATION OF THE LEFT PICA ANEURYSM AND 75% EMBOLIZATION OF THE AVM WERE ACHIEVED. AFTER EMBOLIZATION, ANGIOGRAPHY DEMONSTRATED MINIMAL RESIDUAL SUPPLY TO THE AVM FROM THE BILATERAL SUPERIOR CEREBELLAR ARTERIES AND MILD RESIDUAL SUPPLY FROM THE DISTAL RIGHT PICA. ANGIO-SEAL CLOSURE DEVICE WAS DEPLOYED AT THE BILATERAL FEMORAL ARTERY ACCESS SITES, AND COMPLETE HEMOSTASIS WAS ACHIEVED. PATIENT TOLERATED THE PROCEDURE WELL AND WAS NEUROLOGICALLY INTACT ON EXAM POST-PROCEDURE. NOTABLY, ALTHOUGH HER INITIAL CT HEAD DEMONSTRATED MINIMAL HYDROCEPHALUS, LATER ON IN HER HOSPITAL COURSE, SHE WAS FOUND TO HAVE SIGNIFICANT HYDROCEPHALUS CAUSING ALTERED MENTAL STATUS. A VENTRICULOPERITONEAL SHUNT WAS THEN PLACED WHICH RESTORED THE PATIENT¿S MENTAL STATUS BACK TO BASELINE. AT DISCHARGE, THE PATIENT¿S SYMPTOMS IMPROVED EXCEPT FOR NAUSEA WHICH WAS PRESCRIBED ANTIEMETICS. ON FOLLOW-UP 1 MONTH LATER, THE PATIENT REPORTED NORMAL RETURN TO DAILY ACTIVITIES BUT PERSISTENT NAUSEA UNRESPONSIVE TO MEDICATION. TO TREAT THE RESIDUAL AVM, THE OPTION OF GAMMA KNIFE RADIOSURGERY VERSUS SURGICAL RESECTION WAS DISCUSSED WITH THE PATIENT AND SHE OPTED FOR SURGERY. SUBOCCIPITAL CRANIECTOMY WAS PLANNED FOR RESECTION OF THE RESIDUAL AVM BY THE SENIOR AUTHOR. DURING SURGERY, EXTRAVASATED ONYX WAS ENCOUNTERED AT THE SITE OF THE AVM. THE ONYX WAS VERY ADHERENT TO THE SURROUNDING BLOOD VESSELS, MAKING IT DIFFICULT TO DISSECT AROUND THE ONYX MASS. ULTIMATELY, GROSS TOTAL RESECTION OF THE AVM AS WELL AS THE BULK OF ONYX WAS COMPLETED, AND ADEQUATE HEMOSTASIS WAS ACHIEVED. HISTOLOGIC EXAMINATION SHOWED ABNORMAL TANGLES OF ARTERIESAND VEINS WITHOUT INTERVENING CAPILLARIES CHARACTERISTIC OF AVMS. THE INTRALUMINAL BLACK SPECKS REPRESENT ONYX, AND THE ORANGE DEPOSITS INDICATE PERIVASCULAR HEMOSIDERIN DEPOSITION. POST-OP ANGIOGRAM CONFIRMED COMPLETE RESECTION OF THE AVM WITH NO RESIDUAL. FURTHERMORE, THE PATIENT REPORTED COMPLETE RESOLUTION OF HER NAUSEA AND WAS DISCONTINUED OFF ANTIEMETICS. THE PATIENT TOLERATED THESE PROCEDURES VERY WELL AND REMAINED NEUROLOGICALLY INTACT THROUGHOUT HER HOSPITAL COURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615273 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-7100-060 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention