BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17361235 · Received July 20, 2023

    Report

    Report Number
    2029214-2023-01146
    Event Type
    Injury
    Date Received
    July 20, 2023
    Report Date
    July 20, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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

    FENG, Y., YU, J., XU, J., HE, C., BIAN, L., GUILIN, B., YE, M., HU, P., SUN, L., JIANG, N., LING, F., HONG, T., ZHANG, H. NATURAL HISTORY AND CLINICAL OUTCOMES OF PARAVERTEBRAL ARTERIOVENOUS SHUNTS. 2021. 52: 3873¿3882. DOI: 10.1161/STROKEAHA.120.033963. SUMMARY: SUMMARY: PARAVERTEBRAL ARTERIOVENOUS SHUNTS (PVAVSS) ARE RARE. WHETHER THE INTRADURAL VENOUS SYSTEM IS INVOLVED IN DRAINAGE MAY LEAD TO DIFFERENCES IN CLINICAL CHARACTERISTICS THROUGH SPECIFIC PATHOPHYSIOLOGICAL MECHANISMS. THIS STUDY AIMS TO COMPREHENSIVELY EVALUATE THE NATURAL HISTORY AND CLINICAL OUTCOMES OF PVAVSS WITH OR WITHOUT INTRADURAL DRAINAGE. SIXTY-FOUR CONSECUTIVE PATIENTS WITH PVAVSS FROM 2 INSTITUTES WERE RETROSPECTIVELY REVIEWED. LESIONS WERE CLASSIFIED AS TYPE A (N=28) IF THE INTRADURAL VEINS WERE INVOLVED IN DRAINAGE; OTHERWISE, THEY WERE CLASSIFIED AS TYPE B (N=36). THE CLINICAL COURSE FROM INITIAL PRESENTATION TO THE LAST FOLLOW-UP WAS ANALYZED. THE PATIENTS WITH TYPE A SHUNTS WERE OLDER AT PRESENTATION (52.5 VERSUS 35.5 YEARS, P=0.0253). TYPE A PVAVSS FEATURE RAPID PROGRESSIVE NEUROLOGICAL DEFICITS; THEREFORE, EARLY CLINICAL INTERVENTION IS NECESSARY. FOR COMPLEX LESIONS THAT CANNOT BE COMPLETELY OBLITERATED, SURGICAL DISCONNECTION OF ALL REFLUXED RADICULAR VEINS IS SUGGESTED. REPORTED EVENTS: DURING THE OBSERVATIONAL PERIOD OF 36.9 PATIENT-YEARS AFTER PARTIAL TREATMENT, 5 PATIENTS EXPERIENCED CLINICAL DETERIORATION EVENTS (DETERIORATION RELATED WITH TREATMENT), YIELDING AN OVERALL ANNUAL POSTTREATMENT CLINICAL DETERIORATION RATE OF 13.6%/Y. THE LOG-RANK TEST REVEALED THAT THE RISK OF CLINICAL DETERIORATION IN PATIENTS WITH TYPE A PVAVSS WAS SIGNIFICANTLY HIGHER THAN THAT IN PATIENTS WITH TYPE B SHUNTS (4 EVENTS VERSUS 1 EVENT; 69.9 VERSUS 3.2 PER 100 PERSON-YEARS; P=0.0253) AFTER PARTIAL OBLITERATION (FIGURE 3C).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42728 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention