BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 20341167 · Received October 1, 2024

    Report

    Report Number
    2029214-2024-01718
    Event Type
    Death
    Date Received
    October 1, 2024
    Date of Event
    April 12, 2008
    Report Date
    October 11, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    CONTINUATION OF D10: PRODUCT ID: UNK-NV-MARATHON (UNKNOWN); N/A; PRODUCT ID: UNK-NV-ONYX (UNKNOWN); PRODUCT ID: UNK-NV-MARATHON (UNKNOWN); PRODUCT ID: UNK-NV-ONYX (UNKNOWN); G2: CITATION: AUTHORS: KATSARIDIS, V., PAPAGIANNAKI, C., AIMAR, E. CURATIVE EMBOLIZATION OF CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS) WITH ONYX IN 101 PATIENTS. NEURORADIOLOGY: A JOURNAL DEVOTED TO NEUROIMAGINGAND INTERVE 50(7):589-597 2008. DOI:10.1007 /S00234-008-0382-X EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO ADVERSE EVENTS DESCRIBED IN THIS ARTICLE WERE RELATED TO OR CAUSED BY ANY MEDTRONIC PRODUCTS.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING: "CURATIVE EMBOLIZATION OF CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS) WITH ONYX IN 101 PATIENTS." THE PURPOSE OF THE STUDY IS TO REPORT ON THE INITIAL EXPERIENCE WITH ONYX AS AN EMBOLIC MATERIAL FOR CURATIVE CEREBRAL AVM EMBOLIZATION. THE TIME FRAME OF THIS STUDY WAS: FROM JANUARY 1, 2004, TO DECEMBER 31, 2007. THE FOLLOWING MEDTRONIC DEVICES WERE USED: THE STUDY FOCUSES ON THE USE OF ONYX AS AN EMBOLIC MATERIAL FOR THE TREATMENT OF CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS), ALONG WITH OTHER MATERIALS SUCH AS NBCA, PARTICLES, AND COILS. MICROCATHETERS USED INCLUDE MARATHON. DEATHS OCCURRED IN THE STUDY POPULATION. THE DOCUMENT REPORTS THREE DEATHS AMONG THE 101 PATIENTS TREATED WITH ONYX FOR CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS), RESULTING IN A MORTALITY RATE OF 3%. THE CAUSES OF DEATH WERE: ¿ SEVERE INTRAPARENCHYMAL HEMORRHAGE POST-OPERATIVELY (4 TO 20 HOURS AFTER PROCEDURE): 5 PATIENTS (5%). THIS RESULTED IN THREE DEATHS (3%) DUE TO UNCONTROLLABLE CEREBRAL OR CEREBELLAR EDEMA. SOURCE: PAGES 591, 594-595 AMONG PATIENT ADVERSE EVENTS INCLUDED: COMPLICATIONS AND ADVERSE EVENTS: 1. INTRA-PROCEDURAL COMPLICATIONS: ¿ INTRA-PARENCHYMAL HEMORRHAGE IN THE OCCIPITAL LOBE: 1 PATIENT (0.5%), TREATED SUCCESSFULLY WITH SURGICAL REMOVAL OF HEMATOMA AND MALFORMATION. ¿ SMALL EXTRAVASATION OF ONYX: 7 SESSIONS (3.2%), CLINICALLY INSIGNIFICANT. ¿ MICRO-CATHETER STUCK IN ONYX PLUG: ONE MICRO-CATHETER (1/219, 0.5%) BECAME STUCK IN THE 2-CM ONYX PLUG FOLLOWING A PROLONGED INJECTION (>75 MIN) AND BROKE DURING THE REMOVAL ATTEMPT. THE ATTACHED PART OF THE MICRO-CATHETER WAS LEFT IN THE PERICALLOSAL ARTERY, THE PATIENT WAS PLACED ON ANTIPLATELET TREATMENT AND THERE WERE NO CLINICAL CONSEQUENCES. 2. NEUROLOGICAL DEFICITS: ¿ NEW FOCAL NEUROLOGICAL DEFICIT IN THE IMMEDIATE POST-OPERATIVE PERIOD: 13 PATIENTS (12.9%) (LIMB PARESIS, APHASIA OR VISUAL DISTURBANCES) IN THE IMMEDIATE POST-OPERATIVE PERIOD. THE DEFICIT WAS TEMPORARY IN SEVEN CASES (6.9%) AND PERMANENT IN THE REMAINING SIX (5.9%). IN ALL 13 PATIENTS THE BRAIN COMPUTED TOMOGRAPHY SCAN DISCLOSED NO HEMORRHAGE. 3. DELAYED COMPLICATIONS: ¿ SEVERE INTRAPARENCHYMAL HEMORRHAGE POST-OPERATIVELY (4 TO 20 HOURS AFTER PROCEDURE): 5 PATIENTS (5%). IN ONE THERE WAS A SIGNIFICANT AMOUNT OF ONYX IN THE PRINCIPAL DRAINING VEIN. IN THIS LATTER CASE THE REASON FOR THE HEMORRHAGE WAS APPARENT, BUT IN THE REMAINING FOUR WE SUSPECT THAT OCCLUSION OF THE MAJORITY OF THE BLOOD FLOW INTO THE NIDUS HAD LED TO PROGRESSIVE THROMBOSIS OF THE DRAINING VEINS WITH A SUBSEQUENT LACK OF DRAINAGE OF THE REMAINING PART OF THE MALFORMATION. THREE OF THE HEMORRHAGES MANIFESTED WITH GRAND-MAL SEIZURES FOLLOWED BY COMA, AND THE REMAINING TWO PATIENTS FELL INTO COMA FOLLOWING A FEW MINUTES OF AGITATION AND DISORIENTATION (WITH ONE HEMATOMA IN THE CEREBELLUM). ALL PATIENTS WERE TREATED WITH EMERGENCY CRANIOTOMY AND REMOVAL OF THE HEMATOMA AND OF THE MALFORMATION. THREE OF THESE PATIENTS (3%) DIED DUE TO UNCONTROLLABLE CEREBRAL OR CEREBELLAR EDEMA AND TWO (2%) RECOVERED, ONE WITH MINOR AND ONE WITH MAJOR PERMANENT NEUROLOGICAL DEFICIT. CLINICAL OUTCOMES: 1. TREATMENT RESULTS FOR CONCLUDED THERAPY IN 52 PATIENTS: ¿ TOTAL OCCLUSION OF THE AVM: 28 PATIENTS (53.9%). ¿ NEAR-TOTAL OCCLUSION (>80%): 18 PATIENTS (34.6%). ¿ UNSATISFACTORY OCCLUSION (<(><<)>50%): 3 PATIENTS (5.8%). SUMMARY STATISTICS: ¿ PER SESSION: ¿ PERMANENT MORBIDITY: 3.7% (8 OUT OF 219 SESSIONS). ¿ MORTALITY: 1.4% (3 OUT OF 219 SESSIONS). ¿ PATIENT POPULATION: ¿ PERMANENT MORBIDITY: 8% (8 OUT OF 101 PATIENTS). ¿ MORTALITY: 3% (3 OUT OF 101 PATIENTS). SOURCE: PAGES 591, 594-595 NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949048 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Death SEE H11.