MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number	FA-55150-1030
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Medtronic received a report that the pipeline flex with shield technology stent released as expected, but when slowly advancing the microcatheter to retrieve the ptfe fins (distal protective sleeves), the dps moved the stent.The stent migrated to the neck of the aneurysm and fell into the aneurysm and it was not possible to recover with the microcatheter.No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of an unruptured, fusiform, segment c5 to c6 aneurysm with a max diameter of 15 mm and a 10 mm neck diameter.The landing zone arterial diameter was 4 mm distally and 4.71 mm proximally.It was noted the patient's vessel tortuosity was moderate.The angiographic result post procedure showed image without injury, however, the device stopped fulfilling its function of retaining the flow upon migration into the aneurysm.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The pipeline was used for an approved indication (on-label) and was implanted at the intended location with full wall apposition.No side branches were covered by the pipeline.Medical or surgical intervention was not needed to prevent a permanent impairment of a function, the event did not lead to or extend patient hospitalization, and there was no injury as a result of the event.Additional information received reported that the aneurysm had not been completely closed, and the doctor was considering the possibility of a second procedure.Due to the complex anatomy and the fusiform aneurysm, during the microcatheter's ascent, the diverter became unstable and shifted into the aneurysm.A marksman microcatheter had been used.

• Brand Name: MARKSMAN
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 23633429
• Report Number: 9617601-2025-02953
• Device Sequence Number: 9317452
• Product Code: KRA
• UDI-Device Identifier: 00836462014077
• UDI-Public: (01)00836462014077(17)270701(10)229189495
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K091559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FA-55150-1030
• Device Catalogue Number: FA-55150-1030
• Device Lot Number: 229189495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/24/2025
• Date Device Manufactured: 07/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female