REBAR
Report
- Report Number
- 2029214-2025-02455
- Event Type
- Malfunction
- Date Received
- November 20, 2025
- Date of Event
- November 18, 2025
- Report Date
- December 15, 2025
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- KRA
- 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 SAB-6-30 (LOT: D020436); 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) 6-30 DEVICE THAT HAD RESISTANCE DURING DELIVERY IN A REBAR 18 MICROCATHETER. THE PATIENT WAS UNDERGOING A MECHANICAL THROMBECTOMY PROCEDURE IN A CAROTID ARTERY TO TREAT ISCHEMIC STROKE. THROMBECTOMY IS OFF-LABEL USE FOR THE SOLITAIRE AB WHICH IS INDICATED FOR ADJUNCTIVE TREATMENT OF INTRACRANIAL ANEURYSMS. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV TPA) WAS NOT CONTRAINDICATED IN THIS CASE. PATIENT'S VESSEL TORTUOSITY WAS MODERATE; VESSEL WAS TORTUOUS. IT WAS REPORTED THAT THE SAB AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). A REBAR 18 MICROCATHETER WAS USED TO DELIVER THE SAB. THIS TOO WAS OFF-LABEL USE AS THE IFU INDICATES THE SAB-6-30 SHOULD BE USED WITH MICROCATHETER THAT HAS AN MINIMUM INNER DIAMETER OF 0.027IN, AND REBAR 18 HAS AN INNER DIAMETER OF 0.021IN. DURING DELIVERY, THE SAB BECAME STUCK AT THE DISTAL END OF THE CATHETER AND COULD NOT BE ADVANCED. THE SAB WAS REMOVED AND REPLACED WITH A 4MM SAB STENT, WHICH IS COMPATIBLE FOR USE WITH THE REBAR 18. THE REPLACEMENT SAB WAS DELIVERED WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.
ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE SURGEON WAS UNAWARE THAT THE SAB-6-30 STENT WAS NOT COMPATIBLE FOR USE WITH THE REBAR 18 MICROCATHETER AND REPORTED THAT IT HAD BEEN COMPATIBLE BEFORE. A CONTINUOUS CATHETER FLUSH ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO DAMAGE OBSERVED TO THE CATHETER OR SOLITAIRE AFTER REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 509955 | REBAR | CATHETER, CONTINUOUS FLUSH | KRA | MICRO THERAPEUTICS, INC. DBA EV3 | UNK-NV-REBAR | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |