RIST
Report
- Report Number
- 2029214-2024-01154
- Event Type
- Injury
- Date Received
- July 1, 2024
- Date of Event
- May 2, 2024
- Report Date
- November 1, 2024
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- DQY
- PMA / PMN Number
- K191551
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID: ISF-060-050, (LOT: B614886); PRODUCT TYPE: IMPLANT DATE N/A; EXPLANT DATE N/A. 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. 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 RECEIVED A REPORT THAT THE PATIENT EXPERIENCED A VISUAL FIELD DEFECT POST PROCEDURE ON (B)(6) 2024. THE PATIENT HAD LEFT LATERAL HOMONYMOUS HEMIANOPSIA RELATED TO RIGHT OCCIPITAL LESIONS. IT WAS NOTED THAT IT WAS NOT CORRELATED WITH THE ANGIOGRAPHIC PROCEDURE. THE EVENT RESULTED IN NEW OR WORSENING OF EXISTING NEUROLOGICAL DEFICITS THAT LASTED FOR MORE THAN 24 HOURS. IT WAS ALSO NOTED THAT PER CORELAB IMAGE READ OF THE MR/MRA ON (B)(6) 2024 (POST OP DAY 1), RAYMOND AND ROY OCCLUSION WAS CLASS 3. THERE WAS NO HOSPITALIZATION AND THE EVENT WAS NOT TREATED IN ANOTHER MANNER. THE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. THE SITE ASSESSED AS NOT RELATED TO THE ANTIPLATELET MEDICATION, STUDY DEVICES, OR PROCEDURE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, MIDLINE, SIDEWALL ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 8.6MM AND A 3.5MM NECK DIAMETER. ANEURYSM DOME HEIGHT WAS 8.6MM AND DOME WIDTH WAS 5MM. PARENT ARTERY DIAMETER DISTAL TO ANEURYSM WAS 1.9MM AND PROXIMAL TO ANEURYSM WAS 2.1MM. THERE WAS NO STASIS AT THE END OF THE PROCEDURE.
ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT HAD A CAUSAL RELATIONSHIP TO THE DISEASE UNDER STUDY.
ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS VISUAL DISTURBANCE. CONCOMITANT TREATMENT WAS GIVEN. THE EVENT IS RESOLVING. THE PATENT DEVELOPED TERSON'S SYNDROME.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED TERSON¿S SYNDROME (VISUAL BLURRING) THAT WAS CONFIRMED BY THE OPHTHALMOLOGIST AND WAS TREATED LOCALLY DUE TO THE SUBARACHINOID HEMORRHAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 815632 | RIST | CATHETER, PERCUTANEOUS | DQY | MICRO THERAPEUTICS, INC. DBA EV3 | 107F-079-105V01 | 23423-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other | SEE H11. |