REBAR
Report
- Report Number
- 2029214-2025-00783
- Event Type
- Malfunction
- Date Received
- March 27, 2025
- Date of Event
- March 21, 2025
- Report Date
- May 13, 2025
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- KRA
- UDI-DI
- 00847536026896
- PMA / PMN Number
- K093750
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID SFR-6-30 (D006351); PRODUCT TYPE: 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 RECEIVED A REPORT THAT A SOLITAIRE FR ENCOUNTERED RESISTANCE DURING PREPARATION IN THE MIDDLE SECTION OF THE REBAR CATHETER. IT WAS REPORTED THAT THE SOLITAIRE FR COULD NOT PASS THROUGH THE REBAR MICROCATHETER. AFTER REPEATED ATTEMPTS WITHOUT SUCCESS, IT WAS REPLACED WITH A NEW SFR OF THE SAME MODEL AND SUCCESSFULLY PASSED THROUGH TO THE LESION. THE STENT WAS ABLE TO BE PUSHED OUT OF THE SHEATH. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A REBAR 27 MICROCATHETER.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS BEING TREATED FOR AN ACUTE LARGE ARTERY OCCLUSION. THE BASELINE LESION WAS A RIGHT MIDDLE CEREBRAL ARTERY OCCLUSION. VESSEL TORTUOSITY WAS NORMAL. THE PATIENT'S RECOVERY FROM THE PROCEDURE IS ACCEPTABLE. NO PATIENT SYMPTOMS REPORTED. TICI BASELINE 15, NIHSS BASELINE 1. TICI POSTOPERATIVE 6, NIHSS POSTOPERATIVE 3. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1199724 | REBAR | CATHETER, CONTINUOUS FLUSH | KRA | MICRO THERAPEUTICS, INC. DBA EV3 | 105-5082-145 | B713800 | 00847536026896 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Unknown |