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

Model Number	FG13150-0615-2S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperplasia (1906); Stenosis (2263); Syncope/Fainting (4411); Hemorrhagic Stroke (4417); Ischemia Stroke (4418)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that a patient treated with a ped3 pipeline stent and phenom 21 catheter had strokes.Patient underwent implantation of pipeline vantage 3.5x16 on (b)(6) 2024, without complications during the procedure.On (b)(6), she fainted and was taken to hospital.The diagnostic investigation revealed a hemorrhagic stroke.On the same day, she suffered an ischemic stroke.Angiography was carried out while she was in hospital.Hospitalization and showed severe hyperplasia in the pipeline, resulting in a stenosis of 80/90% stenosis in the m1 segment of the left middle cerebral artery.The patient underwent treatment and was discharged from hospital without motor deficits on (b)(6) 2025.The patient suffered a hemorrhagic stroke 3 months after the vantage pipeline was implanted, and soon after, an ischemic stroke.In the investigation, an angiography was performed and showed a severe hyperplasia in the area where the pipeline was implanted, with arterial stenosis of 80/90%.The patient received drug treatment to control hyperplasia.The patient was hospitalized for 12 days after the hemorrhagic stroke.There was permanent injury.Severe stenosis of the left middle cerebral artery.Angiographic result post procedure was excellent, no flaws in the pipeline apposition.Baseline aneurysm location: communicating segment of the left internal carotid artery (ica).It was an unruptured, saccular aneurysm with a max diameter of 9mm and a neck diameter of 4.7mm.The distal landing zone was 2.75mm and the proximal landing zone was 3.4mm.Vessel tortuosity was moderate.Dual antiplatelet treatment wa administered.The devices were prepared according to the instructions for use (ifu).Ancillary devices: neuron max 0.088" sheath, distal access neuron 0.070 catheter.
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.
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
Additional information was received that actions taken to resolve the stenosis and stroke included only clinical and drug treatment.The doctor believed that the stenosis was caused by severe hyperplasia in the distal segment of the vantage implant and that both the hemorrhagic and ischemic episodes were due to severe stenosis: approximately 80 to 90%.

• Brand Name: CATHERA
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc CA 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc CA 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21810969
• Report Number: 2029214-2025-00938
• Device Sequence Number: 8974550
• Product Code: KRA
• UDI-Device Identifier: 00763000399689
• UDI-Public: 00763000399689
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151638
• 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,Followup
• Report Date (Section B): 05/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FG13150-0615-2S
• Device Catalogue Number: FG13150-0615-2S
• Device Lot Number: 228323972
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/07/2025
• Date Device Manufactured: 02/20/2024
• 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
• Outcome Attributed to Adverse Event: Disability; Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female