BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 20327407 · Received September 27, 2024

    Report

    Report Number
    2029214-2024-01700
    Event Type
    Death
    Date Received
    September 27, 2024
    Date of Event
    May 24, 2023
    Report Date
    October 31, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED FOR THE PATIENT DEATHS REPORTED IN THE LITERATURE ARTICLE. A SEPARATE REPORT WILL BE SUBMITTED FOR SERIOUS INJURIES REPORTED IN THE ARTICLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED CONSERVATIVELY. THE PRIMARY AUTHOR INDICATED THE ADVERSE EVENTS REPORTED IN THE ARTICLE ARE NOT DIRECTLY ASSOCIATED WITH ANY MEDTRONIC PRODUCT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    CHEN, Y., HAN, H., JIN, H., MENG, X., MA, L., LI, R., LI, Z., YAN, D., ZHANG, H., YUAN, K., WANG, K., ZHAO, Y., ZHANG, Y., JIN, W., LI, R., LIN, F., HAO, Q., WANG, H., YE, X., KANG, S., GAO, D., ET AL. (2023). ASSOCIATION OF EMBOLIZATION WITH LONG-TERM OUTCOMES IN BRAIN ARTERIOVENOUS MALFORMATIONS: A PROPENSITY SCORE-MATCHED ANALYSIS USING NATIONWIDE MULTICENTER PROSPECTIVE REGISTRY DATA. INTERNATIONAL JOURNAL OF SURGERY, 109(7), 1900¿1909. HTTPS://DOI.ORG/10.1097/JS9.0000000000000341. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUNDS THAT THE PURPOSE OF THE STUDY WAS TO COMPARE THE LONG-TERM OUTCOMES OF HEMORRHAGIC STROKE OR DEATH IN PATIENTS WITH EITHER CONSERVATIVE MANAGEMENT OR STAND-ALONE EMBOLIZATION FOR BRAIN ARTERIOVENOUS MALFORMATIONS (AVMS). A TOTAL OF 622 (311 PAIRS) PATIENTS CONSTITUTED AN OVERALL STUDY COHORT WHICH INCLUDED 288 CASES (144 PAIRS) INCLUDED IN THE RUPTURED SUBGROUP AND 252 CASES (126 PAIRS) IN THE UNRUPTURED SUBGROUP. A TOTAL OF 311 PATIENTS UNDERWENT EMBOLIZATION TREATMENT AS THE STAND-ALONE MANAGEMENT STRATEGY. PER THE ARTICLE, ONYX LIQUID EMBOLIZATION WAS THE MOST COMMONLY USED EMBOLIC AGENT. NO MALFUNCTION ASSOCIATED WITH. IN THE EMBOLIZATION STUDY COHORT, 8 PATIENTS DIED DURING VARYING FOLLOW-UP PERIODS. THE ARTICLE DOES NOT SPECIFY THE EXACT CAUSES OF PATIENT DEATHS IN THE EMBOLIZATION COHORT. IT PROVIDES COMPARATIVE STATISTICS AND HAZARD RATIOS RELATED TO MORTALITY AND HEMORRHAGIC STROKE BUT DOES NOT DETAIL THE SPECIFIC CAUSES OF DEATH FOR THOSE WHO UNDERWENT EMBOLIZATION. THE ARTICLE ALSO REPORTED PATIENT INJURIES THAT DID NOT RESULT IN DEATH: SPECIFICALLY, IT MENTIONS THAT THERE WERE 14 ISCHEMIC STROKES AND 1 INTRAOPERATIVE HEMORRHAGIC STROKE DURING THE PERIOPERATIVE PERIOD. ADDITIONALLY, THE ARTICLE REPORTS A POSTEMBOLIZATION ANNUAL RUPTURE RATE OF 1.64% IN THE EMBOLIZATION COHORT. HOWEVER, IT IS THE EXACT NUMBER OF PATIENTS WHO EXPERIENCED POSTEMBOLIZATION RUPTURE IN THE EMBOLIZATION COHORT IS NOT EXPLICITLY STATED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THE ADVERSE EVENTS RELATED TO THIS STUDY ONLY COLLECTED LONG-TERM HEMORRHAGIC EVENTS, WHICH WERE NOT DIRECTLY RELATED TO THE MEDTRONIC DEVICES/PRODUCTS. LONG-TERM RUPTURE OF AVM WAS THE BLEEDING OF THE LESION ITSELF AND THEREFORE ASSOCIATED WITH THE PATIENT CONDITION. THERE WAS NO SIGNIFICANT CORRELATION WITH THE EMBOLIZATION MATERIALS. IT WAS NOTED THAT MARATHON CATHETERS WERE ALSO USED IN SOME CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491634 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death