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

Model Number	PED2-475-14
Medical Device Problem Codes	Collapse (1099); Structural Problem (2506); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Hyperplasia (1906); Stenosis (2263)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient with a medical history of patent foramen ovale, transient ischemic attack, and an unruptured left ophthalmic aneurysm previously treated with pipeline embolization underwent 180-day follow-up imaging.The imaging revealed significant parent artery stenosis of 51%-75% and incomplete wall apposition of the pipeline embolization device, which had previously been reported as complete.The findings were confirmed by the core lab and adjudication committee.The poor wall apposition could be attributed to vessel stenosis and intimate hyperplasia.The event was possibly related to antiplatelet medication and had a probable relationship with the study procedure and device.The parent artery stenosis (in stent stenosis) was a finding based on imaging and no symptoms or treatment were reported by the site.Additional information was received reporting that a balloon was used to improve wall apposition.The patient was undergoing surgery for treatment of a saccular, right c6 bifurcation branch aneurysm with a max diameter of 3.8 mm and a 1.9 mm neck diameter.The aneurysm dome height was 3.6 mm, dome width was 3.3 mm.Parent artery diameter distal to aneurysm was 3.7mm.Parent artery diameter proximal to aneurysm was 4.5mm.There was complete stasis at the end of the procedure.There was complete neck coverage at the end of the procedure.Aneurysm occlusion (raymond and roy) at the end of the procedure was class 3.Ophthalmic branches covered with the device.The device was successfully implanted in the patient.There was no device twisting or flattening.Cec adjudicated as possible to index procedure, study device, and antiplatelet therapy.This event was stated to be not due to a device deficiency.Additional information received reported that 1 year follow-up imaging on (b)(6) 2025 reported device flattening.No symptoms or actions taken were reported in association with these findings.
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.

• 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: 23758198
• Report Number: 2029214-2025-02572
• Device Sequence Number: 10170896
• Product Code: OUT
• UDI-Device Identifier: 00763000284602
• UDI-Public: (01)00763000284602(17)251110(10)B476139
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/10/2025
• Device Model Number: PED2-475-14
• Device Catalogue Number: PED2-475-14
• Device Lot Number: B476139
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 06/02/2026
• Date Device Manufactured: 11/11/2022
• 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
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 114 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White