BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX

    MDR report key: 17555665 · Received August 16, 2023

    Report

    Report Number
    2029214-2023-01402
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    May 31, 2021
    Report Date
    August 16, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. NO SPECIFIC DEVICE INFORMATION PROVIDED. 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.

    Description of Event or Problem · 0

    ZHANG, Z., LIU, J., ZHANG, B., ZHOU, M., ZHAO, X., LI, Z. A MODIFIED TREATMENT THROUGH POINT-TO-POINT COIL EMBOLIZATION FOR DIRECT CAROTID CAVERNOUS TO FISTULA: A SINGLE-CENTER RESULT. FRONT. NEUROL. 2021. 12:639552. DOI: 10.3389/FNEUR.2021.639552. SUMMARY: THIS STUDY AIMS TO ASSESS THE SAFETY AND EFFICACY OF THE MODIFIED TREATMENT THROUGH POINT-TO-POINT COIL EMBOLIZATION OF DIRECT CAROTID CAVERNOUS FISTULA (DCCF), AND EVALUATE THE LONG-TERM OUTCOME OF PATIENTS WHO UNDERWENT THE ABOVE TREATMENT. A TOTAL OF 18 PATIENTS WHO SUFFERED FROM DCCF (A TOTAL OF 19 FISTULAS) BETWEEN JANUARY 2013 TO MAY 2020 WERE ANALYZED. AMONG THESE PATIENTS, 14 PATIENTS WERE TREATED THROUGH POINT-TO-POINT COIL EMBOLIZATION OF THE FISTULA, WHILE FOUR PATIENTS WERE TREATED THROUGH COMBINED ENDOVASCULAR EMBOLIZATION (COILS, A BALLOON, ONYX, AND/OR A STENT). THE NUMBER OF COILS THAT FILLED THE FISTULAS WAS COUNTED. THE PRIMARY OUTCOME WAS DEFINED BY POST-OPERATIVE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) OR THE SIGNS AFTER THE RECANALIZATION OF DCCFS DURING THE FOLLOW-UP PERIOD. FOR PATIENTS WITH DCCF WHO UNDERWENT POINT-TO-POINT COIL EMBOLIZATION, A MINIMUM OF THREE COILS AND A MAXIMUM OF 16 COILS WERE USED FOR THESE 14 FISTULA PATIENTS, AND AN AVERAGE OF 7.9 COILS WERE USED FOR EACH FISTULA, BUT NONE OF THE FISTULAS WAS RECANALIZED. FURTHERMORE, TWO PSEUDOANEURYSMS WERE OBSERVED AS A RESULT OF THE COMPRESSION OF THE COILS. HOWEVER, NONE OF THESE 14 PATIENTS PRESENTED WITH SIGNS OF RECANALIZATION OF FISTULAS OR CRANIAL PARALYSIS. THE PROCEDURE APPLIED FOR THE PRESENT STUDY WAS SHOWN TO BE A SAFE, ECONOMICAL AND EFFICACIOUS TREATMENT APPROACH FOR DCCFS THROUGH THE POINT-TO-POINT COIL EMBOLIZATION OF THE FISTULA. REPORTED EVENTS: THE COMBINED ENDOVASCULAR EMBOLIZATION WAS PERFORMED FOR THE CONTROL CASES. IN ADDITION TO THE USE OF COILS, ETHYLENE VINYL ALCOHOL COPOLYMER (ONYX) WAS USED THROUGH A HYPERFORM OCCLUSION BALLOON (EV3, USA). FOR CASE 15 AND 16, THE ONYX WAS INFILTRATED IN THE INTERNAL CAROTID ARTERY, AND A LVIS STENT (MICROVENTION, USA) WAS USED TO COMPRESS AND FIX THE ONYX TO THE VESSEL WALL, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761862 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown