RIST
Report
- Report Number
- 2029214-2026-00287
- Event Type
- Injury
- Date Received
- February 18, 2026
- Date of Event
- May 21, 2025
- Report Date
- April 13, 2026
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
- Product Code
- QJP
- UDI-DI
- 00763000413842
- PMA / PMN Number
- K191551
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- 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.
B5. UPDATED WITH ADDITIONAL INFORMATION RECEIVED. H6. PATIENT CODING UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED. 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.
IT WAS REPORTED THAT, PER CORELAB ASSESSMENT OF TREATMENT IMAGING, THERE WAS THROMBUS AT THE IMPLANT DEVICE ISF-050-040 ARTISSE IN THE FINAL RUN. THE PATIENT HAD A MEDICAL HISTORY OF CONTROLLED HYPERTENSION, PREVIOUS CIGARETTE SMOKING, AND MIGRAINES. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE THROMBUS WAS INSIDE THE DEVICE WITH IMMEDIATE COMPLETE OCCLUSION. IN OUR OPINION THE RESULT IS AS EXPECTED, ADEQUATE AND PERFECT. THE PATIENT SUFFERED NO COMPLICATIONS AND IS ASYMPTOMATIC. THERE IS NO ADVERSE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED TREATMENT IMAGING FROM (B)(6) 2025 THERE WAS THROMBUS AT THE BASIS OF THE ANEURYSM IS CAUSING A ~ 50% STENOSIS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED A HEADACHE ON (B)(6) 2025 ASSOCIATED WITH PHOTOPHOBIA AND SONOPHOBIA REQUIRING RESCUE IV ANALGESIA. THE EVENT DID NOT RESULT IN NEW OR WORSENING OF EXISTING NEUROLOGICAL DEFICITS. THE EVENT WAS RECOV ERED/RESOLVED ON (B)(6) 2025. THE SITE ASSESSED AS CAUSALLY RELATED TO THE DISEASE UNDER STUDY AND PROCEDURE, POSSIBLY RELATED TO THE STUDY DEVICE, AND NOT RELATED TO THE ANTIPLATELET MEDICATION OR ANCILLARY DEVICE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RIGHT CAROTID BIFURCATION ANEURYSM WITH A MAX DIAMETER OF 4.3MM AND A 3.1MM NECK DIAMETER. ANEURYSM DOME HEIGHT WAS 4.3MM AND DOME WIDTH WAS 3.4MM. PARENT ARTERY DIAMETER DISTAL TO ANEURYSM WAS 2.7MM AND PROXIMAL TO ANEURYSM WAS 2.6MM. THERE WAS COMPLETE STASIS AND RAYMOND AND ROY AT THE END OF THE PROCEDURE WAS CLASS 1. ANCILLARY DEVICES INCLUDE PHENOM PLUS CATHETER, RIST CATHETER, AND SIMMONDS 2 5F CATHETER.
ADDITIONAL INFORMATION WAS RECEIVED THAT REGARDING THE SUBDURAL HEMATOMA AND ANEURYSM RUPTURE EVENT PER QUERY RESPONSE, SITE REPORTS ¿THE PATIENT WAS ADMITTED WITH A SPONTANEOUS SUBDURAL HEMATOMA. UPON ADMISSION, A RUPTURED ANEURYSM AND AN INCIDENTAL UNRUPTURED ANEURYSM WERE IDENTIFIED. BOTH WERE TREATED IN THE SAME PROCEDURE, WITH THE UNRUPTURED ANEURYSM TREATED WITH THE ARTISSE DEVICE. THE SUBJECT HAD TWO ANEURYSMS. THE FIRST ONE WAS ACUTELY RUPTURED AND CAUSED SAH. IN THE SAME INTERVENTION OF THE FIRST ONE, A SECOND ONE NOT RUPTURED WAS ALSO TREATED. THIS LAST ONE WAS TREATED WITH ARTISSE DEVICE". THE CAUSE WAS NOT DETERMINED NOR WAS A RELATIONSHIP TO THE PROCEDURE, RIST CATHETER OR PHENOM PLUS CATHETER REPORTED. NO ADDITIONAL INTERVENTIONS WERE REPORTED.
ADDITIONAL INFORMATION RECEIVED THAT THE PATIENTS HOSPITALIZATION HAS NOW BEEN PROLONGED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT A PROGRESS NOTE FROM PATIENT'S 4TH DAY POST-OPERATIVE IN ICU THE PATIENT THE PATIENT HAD EXPERIENCED SUBDURAL HEMATOMA DUE TO ANEURYSM RUPTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 140608 | RIST | CATHETER, PERCUTANEOUS, NEUROVASCULATURE | QJP | MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA | 107F-079-100 | 25662-01 | 00763000413842 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |