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

Model Number	PED3-027-450-16
Medical Device Problem Codes	Structural Problem (2506); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Hyperplasia (1906)
Date of Event	04/07/2025
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 upon follow up on (b)(6) 2025, the physician noticed severe intimal hyperplasia and fish mouthing of the pipeline distally.The patient was undergoing surgery for treatment of a saccular, unruptured left internal carotid artery (ica) - supraclinoid aneurysm with a max diameter of 5mm and a 4mm neck diameter.Landing zone: distal: 4.25mm and proximal: 4.3mm.It was noted the patient's vessel tortuosity was moderate.The angiographic result was satisfactory post pipeline placement.The stent was compressed a little.The pipeline was used for an indication that is approved (on-label).The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).There were patient symptoms or complications associated with this event including severe intimal hyperplasia and fish mouthing of the distal end of the device.Additional information received reported that the patient was kept on dapt to resolve the hyperplasia and fish mouthing.The distal end was fish mouthed and the device was compressed.The cause of the hyperplasia and fish mouthing was not determined.Ancillary devices include a sheath, phenom plus guide catheter, phenom 27 microcatheter, and aristotle guidewire.

• Brand Name: PIPELINE VANTAGE WITH 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: 22787747
• Report Number: 2029214-2025-01808
• Device Sequence Number: 15513126
• Product Code: OUT
• UDI-Device Identifier: 00847536036802
• UDI-Public: (01)00847536036802(17)270710(10)B757645
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PED3-027-450-16
• Device Catalogue Number: PED3-027-450-16
• Device Lot Number: B757645
• 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: 08/12/2025
• Initial Report FDA Received Date: 08/12/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1245-2025
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Male
• Patient Weight: 82 KG