MARKSMAN
Report
- Report Number
- 9617601-2025-02460
- Event Type
- Malfunction
- Date Received
- November 3, 2025
- Date of Event
- November 1, 2025
- Report Date
- December 8, 2025
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- KRA
- UDI-DI
- 00836462014077
- PMA / PMN Number
- K091559
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTING REQUIREMENTS IN 21CFR 803.¿ 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.
CONTINUATION OF D10: PIPELINE FLEX STENT PRODUCT ID PED-500-30 (LOT D020152); 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.
ADDITIONAL INFORMATION WAS RECEIVED. ONLY ONE MARKSMAN CATHETER (PLI20) WAS USED WITH THE SAME STENT, WITH THE SAME COMPLAINT REPORTED FOR BOTH.
MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX STENT COULD NOT BE OPENED. AFTER SEVERAL ATTEMPTS, THE STENT COULD NO LONGER BE RETRIEVED OR DEPLOYED. DAMAGE TO THE MARKSMAN CATHETERS WAS SUSPECTED, SO IT WAS REMOVED. THE STENT AND MARKSMAN CATHETERS WERE REPLACED WITH MEDTRONIC PRODUCTS TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, FUSIFORM, RIGHT VERTEBRAL ARTERY V4 WITH A MAX DIAMETER OF 6 MM AND A 5 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 4.2 MM DISTALLY AND 4.7 MM PROXIMALLY. FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 9 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL-MODERATE. THE PATIENT HAS A HISTORY OF HYPERTENSION. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PLATELET REACTIVITY UNIT (PRU) LEVEL WAS NOTED AS MEETING STANDARDS. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED SMOOTH BLOOD FLOW. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). ANCILLARY DEVICES INCLUDED A NAVIEN RFX058-115-08 INTRACRANIAL SUPPORT CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1480921 | MARKSMAN | CATHETER, CONTINUOUS FLUSH | KRA | MEDTRONIC MEXICO S. DE R.L. DE CV | FA-55150-1030 | 229379785 | 00836462014077 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | SEE H11... |