BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 14612830 · Received June 7, 2022

    Report

    Report Number
    2029214-2022-00951
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    May 29, 2022
    Report Date
    June 10, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. 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

    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

    MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH ONYX 18 LES HAD A MULTIFOCAL BRAIN INFARCTION. THE EVENT WAS POST-PROCEDURE. THE PATIENT WAS DISABLED AND MEDICAL INTERVENTION WAS REQUIRED.  BASELINE  SUBDURAL HEMATOMA (SDH) CHARACTERISTICS. FRONTAL. HEMATOMA THICKNESS: 15 MM. MIDLINE SHIFT: 2.5 MM.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED PATEINT HAD NO IMMEDIATE COMPLICATION, BUT ULTIMATELY DIED >3 MONTHS AFTER EMBOSURGERY FROM MULTI-ORGAN FAILURE THAT WAS PRECIPITATED BY INTRAPARENCHYMAL BRAIN BLEED UNRELATED TO SDH AND UNRELATED TO THE EMBOSURGERY. AT THE TIME OF HIS NEW INTRACRANIAL HEMORRHAGE, PT HAD UNDERLYING TYPE 2 DIABETES MELLITUS, ESSENTIAL HYPERTENSION (CHRONIC), GERD (CHRONIC), CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CIRRHOSIS (CHRONIC) AND THROMBOCYTOPENIA. PATEINT HAD A BLEED, NOT AN INFARCTION. HE PRESENTED WITH SUDDEN COLLAPSE/UNCONSCIOUSNESS. HE HAD SEVERAL POST-OP CT HEAD SCANS FOLLOWING HIS (B)(6) 2022 ONYX EMBOSURGERY (INCLUDING MARCH 28), AND THEN MORE HEAD CTS BEGINNING WITH HIS BRAIN BLEED (B)(6) 2022 BECAUSE THE BLEED WAS CONSIDERED A HYPERTENSIVE BASAL GANGLIA/THALAMIC HEMORRHAGE, SUPPORTIVE (MEDICAL) CARE WAS PROVIDED BY THE ICU STAFF. THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS COMPLETED SUCCESSFULLY. MRI-HEAD OBTAINED ON 29- MAY-2022 REVEALED ACUTE INFARCTION IN THE RIGHT CAUDATE HEAD, LEFT CEREBELLAR HEMISPHERE, AND LEFT MIDBRAIN. FURTHER WORKUP REVEALED BILATERAL LOWER EXTREMITIES DEEP VENOUS THROMBOSIS AND RIGHT TO LEFT INTRACARDIAC SHUNT. NEUROLOGY CONSULT STATED MULTIFOCAL ISCHEMIC STROKE ETIOLOGY LIKELY CA RDIOEMBOLIC. THE EVENTS WERE ASSESSED TO BE NOT RELATED TO STUDY DEVICE OR PROCEDURE. SEE (B)(4) FOR INFORMATION REGARDING PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542355 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-7100-060 B181057

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Disability| R