REBAR
Report
- Report Number
- 2029214-2025-01119
- Event Type
- Malfunction
- Date Received
- May 4, 2025
- Date of Event
- April 5, 2025
- Report Date
- July 17, 2025
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- KRA
- UDI-DI
- 00847536026834
- PMA / PMN Number
- K093750
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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 RECEIVED INFORMATION REGARDING A SOLITAIRE AB (SAB) THAT HAD RESISTANCE IN THE CATHETER AND WAS KINKED/DAMAGED. THE PATIENT WAS UNDERGOING AN EMERGENCY THROMBECTOMY PROCEDURE USING SWIM TECHNIQUE TO TREAT ISCHEMIC STROKE IN THE MIDDLE CEREBRAL ARTERY (MCA). THE PATIENT'S BASELINE MRS WAS 3, NIHSS WAS 15, AND TICI WAS 0. PATIENT VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE SAB AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS DELIVERED IN PLACE WITH THE GUIDEWIRE AND DELIVERY OF THE SAB STENT WAS INITIATED. DURING THE DELIVERY PROCESS, THE SAB EXPERIENCED RESISTANCE NEAR THE CATHETER HUB. THE SURGEON ADJUSTED THE COAXIAL SYSTEM, PUSHING THE INTERMEDIATE CATHETER UPPER, AND CONTINUED TO TRY ADVANCING THE SAB. HOWEVER, THE RESISTANCE WAS STILL SIGNIFICANT THROUGH THE DISTAL END OF THE CATHETER. THE SAB WAS WITHDRAWN AND INSPECTED BUT IT APPEARED NORMAL SO IT WAS RESHEATHED AND DELIVERY WAS REATTEMPTED. THE RESISTANCE DURING DELIVERY IN THE DISTAL CATHETER REMAINED SO IT WAS AGAIN WITHDRAWN. AT THAT TIME, THE SOLITAIRE STENT WAS KINKED/BENT NEAR THE DETACHMENT POINT. TWO PASSES WERE MADE WITH THE DEVICE. THE SOLITAIRE AB WAS REPLACED WITH ANOTHER OF THE SAME MODEL WHICH WAS DELIVERED AND DEPLOYED SMOOTHLY TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT. STROKE ONSET TO REPERFUSION TIME WAS 4 HOURS; TICI 3 WAS ACHIEVED. POSTOPERATIVE MRS REMAINED 3, NIHSS WAS IMPROVED TO 4. ADDITIONAL INFORMATION RECEIVED REPORTED CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE AND KINK/DAMAGE WAS NOT DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1871514 | REBAR | CATHETER, CONTINUOUS FLUSH | KRA | MICRO THERAPEUTICS, INC. DBA EV3 | 105-5081-153 | B762167 | 00847536026834 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female |