MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED2-400-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Blurred Vision (2137); Stenosis (2263)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that a patient treated with a ped2 pipeline stent had complications.Subject came to the emergency room with complaints of headache and blurry of vision, prior mra head revealed bilateral carotid stenosis.The patient was hospitalized form (b)(6) 2025.The event resolved on 2025-jun-19.Assessed as possibly related to procedure, disease under study and antiplatelet medication and probably related to study device.3 year follow-up imaging that branches arising from the parent artery have a degree of stenosis: - ophthalmic; 76%-95%.Mrs score at 3 year visit of 1 however mrs score at 1 year visit was 0.Baseline aneurysm details: side (hemisphere): righ.T segment of internal carotid artery (ica): c6.Location of aneurysm in vessel: sidewall.Aneurysm morphology: saccular.Maximum aneurysm diameter: 5mm.Aneurysm dome height: 4mm.Aneurysm dome width: 3mm.Aneurysm neck size: 3mm.Parent artery diameter distal to aneurysm: 3mm.Parent artery diameter proximal to aneurysm: 4mm.No stasis at the end of the procedure.
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
Additional information received that file report 2029214-2025-01556 is related and merged into 2029214-2022-02080.Any additional supplemental information will be reported from 2029214-2022-02080.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.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 22468844
• Report Number: 2029214-2025-01556
• Device Sequence Number: 19901640
• Product Code: OUT
• UDI-Device Identifier: 00763000284336
• UDI-Public: (01)00763000284336(17)250216(10)B340429
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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 Expiration Date: 02/16/2025
• Device Model Number: PED2-400-14
• Device Catalogue Number: PED2-400-14
• Device Lot Number: B340429
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 02/25/2026
• Date Device Manufactured: 02/17/2022
• 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: Hospitalization
• Patient Sex: Female
• Patient Weight: 78 KG