BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17401840 · Received July 26, 2023

    Report

    Report Number
    2029214-2023-01188
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    January 25, 2013
    Report Date
    July 26, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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.

    Description of Event or Problem · 0

    L. PIEROT. C. COGNARD. D. HERBRETEAU. H. FRANSEN. W. J. VAN ROOIJ. E. BOCCARDI. A. BELTRAMELLO. N. SOUROUR. K. KUPCS.A. BIONDI. A. BONAFÉ. W. REITH. A. CASASCO; EUR RADIO; 2013; 23:2838¿2845; ENDOVASCULAR TREATMENT OF BRAIN ARTERIOVENOUS MALFORMATIONS USING A LIQUID EMBOLIC AGENT: RESULTS OF A PROSPECTIVE, MULTICENTRE STUDY (BRAVO); DOI 10.1007/S00330-013-2870-6. MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE OF PATIENTS TREATED WITH ONYX EMBOLIZATION AND MIRAGE GUIDEWIRES HAVING COMPLICATIONS. THE PURPODE OF THE ARTICLE WAS TO EVALUATE THE SAFETY AND EFFICACY OF A NEW LIQUID EMBOLIC AGENT IN BRAIN ARTERIOVENOUS MALFORMATION (BAVMS) EMBOLISATION. THE ENTRY CRITERION WAS UNTREATED BRAIN ARTERIOVENOUS MALFORMATIONS (AVM) WHATEVER THE CLINICAL PRESENTATION AND LOCATION. PATIENTS WERE EXCLUDED IF THEY WERE UNDER THE AGE OF 18, PREGNANT, UNABLE TO GIVE INFORMED CONSENT OR HAD EXPERI ENCED RECENT INTRACRANIAL BLEEDING. ON (DECEMBER 2005 TO DECEMBER 2008, 117 PATIENTS (72 MALE; 45 FEMALE, AGED 18¿75 YEARS) WERE INCLUDED. CLINICAL PRESENTATION WAS MOSTLY HAEMORRHAGE (34.2 %) AND SEIZURES (28.2 %). MOST AVMS WERE LOCATED IN THE BRAIN HEMISPHERES (85.5 %). PROCEDURE: PROCEDURES WERE PERFORMED WITH THE PATIENTS UNDER GENERAL ANAESTHESIA. THE STEPS OF THE PROCEDURES STARTED WITH THE SUPERSELECTIVE CATHETERISATION OF THE NIDUS USING A DMSO (DI-METHYL-SULPHOXIDE)-COMPATIBLE MICROCATHETER AND MICROGUIDEWIRE (ULTRAFLOW AND MIRAGE). THE MICROCATHETER TIP WAS PLACED AS CLOSE AS POSSIBLE TO THE AVM NIDUS. BEFORE INJECTIONOF ONYX, THE MICROCATHETER WAS FLUSHED WITH NORMAL SALINE AND THE CATHETER DEAD SPACE WAS FILLED WITH 0.25 ML OF DMSO. THEN 0.25 ML OF ONYX WAS SLOWLY INJECTED (OVER 60 S) TO FILL THE MICROCATHETER AND REPLACE THE DMSO IN THE CATHETER DEAD SPACE. THE SLOW INJECTION OF ONYX WAS THEN CONTINUED UNDER FLUOROSCOPY. IN THE CASE OF REFLUX, THE INJECTION WAS STOPPED FOR 2 MIN. IN THE CASE OF VENOUS PASSAGE, THE INJECTION WAS BRIEFLY STOPPED. VARIOUS TECHNIQUES WERE USED TO WITHDRAW THE MICROCATHETER. UP TO SIX EMBOLISATION SESSIONS/PATIENT WERE PERFORMED WITH A MEAN OF 2.03±1.10 SESSIONS (MEDIAN=2.0). A TOTAL OF 237 EMBOLISATION SESSIONS WERE PERFORMED: 187 WITH ONYX ALONE, 38 WITH 2 EMBOLIC AGENTS (ONYX AND GLUE: 37, ONYX AND COILS: 1) AND 12 WITH GLUE ALONE. COMPLICATIONS: ACCESS SITE COMPLICATIONS (NEEDING SURGERY) WERE OBSERVED IN 2/117 PATIENTS (1.7 %). PERFORATION OR DISSECTION OF THE FEEDING PEDICLE WAS OBSERVED IN 5/117 PATIENTS (4.3 %). A TREATMENT WAS PERFORMED IN TWO OF THEM (SURGERY IN 1 PATIENT, GLUE EMBOLISATION IN THE OTHER). NO CLINICAL WORSENING WAS OBSERVED AS A RESULT OF THESE COMPLICATIONS IN THE FIVE PATIENTS. TREATMENT-RELATED BLEEDING WAS OBSERVED IN10/117 CASES (8.5 %). SURGICAL TREATMENT WAS PERFORMED IN FOUR PATIENTS. CLINICAL OUTCOME WAS DEATH IN FOUR PATIENTS, CLINICAL WORSENING IN TWO PATIENTS (MRS 4 AND 5), AND NO CLINICAL CHANGE IN FOUR CASES. THE RATE OF TREATMENT-RELATED BLEEDING WAS SIMILAR IN AVMS 3 CM (5/61, 8.2 %) AND AVMS=3 CM (5/56, 8.9 %; P=1.00). IT WAS HIGHER IN UNRUPTURED AVMS (9/77, 11.7 %) THAN IN RUPTURED AVMS (1/40, 2.5 %), BUT NOT SIGNIFICANTLY (P=0.16). TRANSIENT NON-HAEMORRHAGIC DEFICITS WERE OBSERVED IN 9/117 PATIENTS (7.7 %) AND PERMANENT DEFICITS IN 7/117 PATIENTS (6.0 %). IN THIS LAST GROUP, 1-MONTH MRS WAS ONE IN ONE PATIENT, TWO IN TWO PATIENTS, THREE IN TWO PATIENTS AND FOUR IN TWO PATIENTS. ONE PATIENT HAD EXTENSIVE VENOUS THROMBOSIS AFTER ONYX EMBOLISATION AND EVENTUALLY DIED. TWO PATIENTS HAD LATE INTRACRANIAL BLEEDING (2 AND 8 MONTHS AFTER EMBOLISATION SESSIONS) AND EVENTUALLY DIED. MORBIDITY WAS OBSERVED IN 6/117 PATIENTS (5.1 %), AND WAS RELATED TO HAEMORRHAGIC EVENTS IN 2 CASES AND NON-HAEMORRHAGIC COMPLICATIONS IN 4 CASES. FIVE PATIENTS (4.3 %) DIED IN RELATION TO THE TREATMENT, FOUR IN RELATION TO EARLY BLEEDING AND ONE BECAUSE OF EXTENSIVE VENOUS THROMBOSIS. ONE HUNDRED PERCENT OCCLUSION WAS REPORTED FOR 27/115 PATIENTS (23.5 %), 99¿75 % OCCLUSION IN 39/115 PATIENTS (33.9 %), 75¿50 % OCCLUSION IN 32/115 PATIENTS (27.8 %) AND 50 % OCCLUSION IN 17/115 PATIENTS (14.8 %). THE PERCENTAGE OF COMPLETE AVM OCCLUSION WAS BETWEEN 0.0 % AND 33.3 % FROM ONE CENTRE TO ANOTHER. ONE HUNDRED PER CENT OCCLUSION WAS REPORTED IN 23/61 PATIENTS (37.7 %) WITH AVMS 3 CMAND 4/53 PATIENTS (7.6 %) WITH AVMS=3 CM (P 0.0001). TOTAL OCCLUSION WAS MORE FREQUENTLY OBTAINED IN RUPTURED AVMS (32.5 %) THAN IN UNRUPTURED AVMS (18.7 %; P=0.11). COMPLEMENTARY TREATMENT WAS PERFORMED IN 65/79 SURVIVING PATIENTS (82.3 %) WITH PARTIAL AVM OCCLUSION: RADIOSURGERY IN 56 PATIENTS (FIG. 2) AND SURGERY IN 9 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817235 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Required Intervention