ONYX
Report
- Report Number
- 2029214-2023-01018
- Event Type
- Injury
- Date Received
- July 6, 2023
- Date of Event
- May 28, 2020
- Report Date
- August 2, 2023
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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.
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.
TUMUL CHOWDHURY, ABANOUB A. RIZK, EMAD AL AZAZI, LASHMI VENKATRAGHAVAN, JAI S. SHANKAR, AND BERNHARD SCHALLER; JOURNAL OF NEUROSURGICAL ANESTHESIOLOGY; 2022; VOLUME 34, NUMBER 3; BRAIN AND HEART CROSSTALK DURING NEUROINTERVENTIONAL PROCEDURES: THE ROLE OF THE TRIGEMINOCARDIAC REFLEX: AN UPDATED SYSTEMATIC REVIEW; DOI: 10.1097/ANA.0000000000000723 MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE OF PATIENTS TREATED WITH ONYX HAVING COMPLICATIONS. THE ARTICLE WAS A STEMATIC REVIEW THAT AIMED TO PROVIDE AGGREGATED INFORMATION RELATED TO THE E TRIGEMINO CARDIAC REFLEX (TCR) DURING NEUROINTERVENTIONAL PROCEDURES AND TO IMPROVE UNDERSTANDING OF THE VARIOUS MECHA NISMS THAT CAN INCITE THIS UNIQUE BRAIN-HEART CROSSTALK. THE TCR WAS DEFINED AS A DECREASE OF >20% IN MEAN HEART RATE AND/OR MEAN ARTERIAL PRESSURE. THE OUTCOME OF TCR EPISODES WAS DETERMINED BY THE PRESENCE OR ABSENCE OF NEW NEUROLOGICAL DEFICITS (EITHER INTRAOPERATIVELY OR POSTOPERATIVELY) AND CATEGORIZED AS GOOD OR BAD. THE ABSENCE OF A NEW NEUROLOGICAL DEFICIT, OR THE RESOLUTIO N OF A NEW DEFICIT AT HOSPITAL DISCHARGE, WAS CLASSIFIED AS A GOOD OUTCOME, WHEREAS A NEW NEUROLOGICAL DEFICIT PERSISTING AT HOSPITAL DISCHARGE WAS CLASSIFIED AS A BAD OUTCOME. BAD OUTCOMES WERE FURTHER CLASSIFIED AS DIRECT OR INDIRECT, RESPECTIVELY, IF THE ARTICL E(S) NOTED THAT THE TCR EPISODES WERE RELATED TO THE BAD OUTCOME OR DID NOT MENTION THE TCR AS THE CAUSE OF ANY ADVERSE OUTCOME. PRIMARY FINDINGS: IN THE ARTICLES INCLUDED IN THIS REVIEW, 32 OF 221 (14.5%) PATIENTS WERE REPORTED TO HAVE TCR EPISODES DURING A NEUROINTERVENTIONAL PROCEDURE. THE MALE AND FEMALE DISTRIBUTION OF THE TCR EPISODES WAS ALMOST EQUAL ,AND MOST OCCURRED IN MIDDLE-AGED PATIENTS. THE MAJORITY (27/32; 84.4%) OF THE REPORTED TCR EPISODES WERE OF MODERATE SEVERITY, 2 WERE MILD AND 3 SEVERE. INVARIABLY, THE TCR EPISODES WERE RELATED TO THE EMBOLIZATION STEP OF THE PROCEDURE, EITHER DURING OR JUST AFTER INJECTION OF THE EMBOLIZATION MATERIAL. THE MOST COMMON INCITING MECHANISM FOR THE TCR WAS A CHEMICAL TRIGGER (40%) FOLLOWED BY MECHANICAL STRETCH (25%); A MIXED MECHANISM (BOTH CHEMICAL AND MECHANICAL) WAS RESPONSIBLE FOR ~1 IN 5 PATIENTS. SECONDARY FINDINGS: TWENTY-NINE PATIENTS (90.6%) HAD A GOOD OUTCOME AFTER THE TCR EPISODE(S). ALTHOUGH 3 PATIENTS HAD BAD OUTCOMES, THESE WERE NOT DIREC TLY RELATED TO THE TCR EPISODE. THIRTY PATIENTS (93.8%) WITH A TCR EPISODE RECEIVED GENERAL ANESTHESIA (GA), SO THE PLANNED COMPARISON BETWEEN GA AND LOCAL ANESTHESIA (LA) WAS NOT PERFORMED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT WAS NOT RELATED TO ANY SPECIFIC COMPANY RELATED PRODUCTS AS IT WAS NOT POINTED OUT IN THOSE INCLUDED STUDIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1788273 | ONYX | AGENT, INJECTABLE, EMBOLIC | MFE | MICRO THERAPEUTICS, INC. DBA EV3 | UNK-NV-ONYX | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Unknown | Required Intervention |