PIPELINE FLEX
Report
- Report Number
- 2029214-2025-01223
- Event Type
- Malfunction
- Date Received
- May 20, 2025
- Date of Event
- May 17, 2025
- Report Date
- June 6, 2025
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- 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 A REPORT THAT A PHENOM CATHETER WAS KINKED AT THE DISTAL END. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT¿S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL DIAMETER WAS 5 MM. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS BEING TREATED FOR A LEFT OPHTHALMIC ARTERY ANEURYSM. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. AFTER THE MICROCATHETER (FG15150-0615-1S, (B)(6)) WAS IN PLACE, THE SURGEON BEGAN TO DELIVER THE STENT (PED-425-18, B789001). DURING THE DELIVERY PROCESS, THE RESISTANCE WAS VERY LARGE, BUT THE DELIVERY WAS CONTINUED. AFTER DEPLOYING A LONG ENOUGH STENT IN THE STRAIGHT SECTION OF M1, IT WAS FOUND THAT THE STENT COULD NOT BE OPENED. AFTER REPEATED OPERATIONS FOR MORE THAN TEN MINUTES, IT STILL COULD NOT BE OPENED. FEARING THAT THE STENT WOULD BE DAMAGED, IT WAS WITHDRAWN FROM THE BODY FOR INSPECTION. IT WAS FOUND THAT THE DISTAL END OF THE TUBE WAS KINKED. THE STENT COULD BE PUSHED OUT IN VITRO AND THE TIP END WAS NOT DAMAGED. THEREFORE, IT WAS REPLACED WITH A NEW MICROCATHETER (FG15150-0615-1S, (B)(6)). THE STENT WAS RE-PUSHED TO GO UPPER, AND THE STENT WAS DEPLOYED TO COMPLETE THE OPERATION SMOOTHLY.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE, CAVERNOUS SINUS GRADE 3. THE RESISTANCE WAS IN THE DISTAL SOFT SEGMENT OF THE CATHETER. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE PIPELINE TIP DID NOT OPEN. THE DEVICE WAS LOCATED IN A STRAIGHT SECTION OF THE M1 SEGMENT AT THE TIME. THEY HAD TRIED TO PUSH THE LONG SHEATH AND THE MIDDLE CATHETER UPPER, PROVIDED MORE SUPPORT, AND THE TIP OF STENT WAS DEPLOYED TO A GREATER LENGTH, BUT IT STILL COULD NOT BE OPENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2185462 | PIPELINE FLEX | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED-425-18 | B789001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female |