BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 14139275 · Received April 18, 2022

    Report

    Report Number
    2029214-2022-00656
    Event Type
    Injury
    Date Received
    April 18, 2022
    Date of Event
    April 14, 2022
    Report Date
    May 18, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ASSOCIATED REGULATORY REPORT: 2029214-2022-00654. 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 A REPORT THAT AFTER THE MICROCATHETER WAS IN PLACE AND THE GLUE WAS BEING APPLIED, IT WAS FOUND THAT THERE WAS NO GLUE SPILLAGE AT THE DISTAL END. DURING ANGIOGRAPHY, IT WAS FOUND THAT AT THE PETROUS SEGMENT VESSEL OF THE CAROTID ARTERY, THERE WAS AN ONYX OVERFLOW AND HAD BLOCKED A BLOOD VESSEL. THE SURGEON REMOVED THE MICROCATHETER, AND IT WAS FOUND THAT THE PROXIMAL END OF THE SOFT SEGMENT OF THE CATHETER WAS RUPTURED. THE SURGERY WAS STOPPED AFTER ANGIOGRAPHY. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE CATHETER WAS RUPTURED AT THE DISTAL END. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY AND THERE WAS NO OTHER DAMAGE TO THE CATHETER. THE INJECTION RATE WAS 0.15/MIN. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THE LEFT ANGIOGRAPHY COULD ONLY DEVELOP TO THE C2 SEGMENT. THE DISTAL WAS BLOCKED AND UNABLE TO DEVELOP. THE PATIENT UNDERWENT TREATMENT FOR AN ARTERIOVENOUS MALFORMATION IN THE ANTERIOR CEREBRAL ARTERY. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THE ANATOMICAL LOCATION OF THE APOLLO TIP WAS IN THE MIDDLE CEREBRAL ARTERY. AFTER THE SURGERY, THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT. THE SURGEON DID NOT FOLLOW UP SUBSEQUENTLY. NO ADVERSE EVENTS BEEN TO REPORTED. THE ANATOMY TORTUOUS WAS MODERATE. NO DAMAGE WAS NOTED BEFORE SURGERY, IT WAS RUPTURED DURING SURGERY. IT WAS ALSO NOTED THAT THERE WAS DAMAGED IN THE SOFT SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2626428 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-7000-060 B271709

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male