ONYX
Report
- Report Number
- 2029214-2024-01204
- Event Type
- Injury
- Date Received
- July 11, 2024
- Date of Event
- June 25, 2024
- Report Date
- August 29, 2024
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
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.
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.
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.
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.
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 INFORMATION RECEIVED REPORTED AN ACUTE INFARCT IN THE LEFT BASAL GANGLIA. THE PATIENT WAS RECOVERING/RESOLVING. CT OF THE BRAIN SHOWED REDUCED DIFFUSION IN THE LEFT BASAL GANGLIA CONSISTENT WITH AN ACUTE INFARCT, ACUTE LEFT THALAMOCAPSULAR ISCHEMIC STROKE. ETIOLOGY WAS EITHER CARDIOEMBOLIC IN THE SETTING OF A-FIB OFF ANTICOAGULATION VERSUS SMALL VESSEL DISEASE GIVEN LOCATION.
ADDITIONAL INFORMATION RECEIVED REPORTED 1.3 ML OF ONYX (LOT B72130) WITH DMSO (LOT B694584 AND B702929). NO OTHER EMBOLIZATION METHODS WERE NOTED. NO INTRAARTERIAL LIDOCAINE WAS GIVEN PRIOR TO EMBOLIZATION.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD TROUBLE FINDING WORDS. THE EVENT WAS NOT ASSOCIATED WITH A SEIZURE. THERE WAS NO DECLINE IN MRS. THE EVENT WAS NOT A RESULT OF A DEVICE DEFICIENCY.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS ALREADY USING ANTIPLATELET AND ANTICOAGULANT IN ADMISSION BUT AFTER DIAGNOSIS OF SUBDURAL HEMATOMA (SDH) THEY HAD PLANNED TO HOLD OFF ON THE ANTIPLATELET AND ANTICOAGULANT UNTIL NEXT CT IMAGING IN JULY. THEY THEN PLANNED TO RESTART ANTIPLATELET/ANTICOAGULANT. HOWEVER, BECAUSE OF THE INFARCT THAT WAS SEEN ON CT AND MRI, THE SITE WAS DISCUSSING TO RESTART THE ANTIPLATELET NOW.
MEDTRONIC RECEIVED A REPORT THAT AN ONYX PATIENT UNDERWENT EMBOLIZATION OF BILATERAL MIDDLE MENINGEAL ARTERIES FOR TREATMENT OF BILATERAL CHRONIC SUBDURAL HEMATOMAS. THE PATIENT WAS UNABLE TO HAVE THE RIGHT MIDDLE MENINGEAL ARTERY EMBOLIZATION DUE TO DANGEROUS ANASTOMOSIS TO THE OPHTHALMIC ARTERY, BUT THE LEFT MIDDLE MENINGEAL ARTERY WAS EMBOLIZED. ON (B)(6) 2024, THE SUBJECT WAS READMITTED TO THE HOSPITAL FOR LIGHTHEADEDNESS, DIZZINESS, DECREASED APPETITE AND GENERALIZED WEAKNESS. IMAGING SHOWED A LEFT BASAL GANGLIA INFARCTION. THE EVENT WAS NOTED AS POSSIBLY RELATED TO THE MMA EMBOLIZATION PROCEDURE. ONYX WAS NOT SUCCESSFULLY IMPLANTED IN THE RIGHT MIDDLE MENINGEAL ARTERY, BUT WAS IMPLANTED IN THE LEFT MIDDLE MENINGEAL ARTERY. THE PATIENT¿S VESSEL TORTUOSITY WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2348432 | ONYX | AGENT, INJECTABLE, EMBOLIC | MFE | MICRO THERAPEUTICS, INC. DBA EV3 | UNK-NV-ONYX | B721380 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Male | Hospitalization |