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	Activation, Positioning or Separation Problem (2906); Activation Failure (3270)
Health Effect - Clinical Codes	Hyperplasia (1906); Stenosis (2263)
Date of Event	06/13/2024
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
It was reported that during a neurovascular flow diversion procedure involving the pipeline vantage with shield technology, intimal hyperplasia formation occurred around the proximal end of the stent, causing stenosis.Mal apposition was noted at the proximal end of the device, necessitating balloon angioplasty during the original procedure.The angiographic result post-procedure appeared satisfactory.At a 6-month follow-up, significant intimal hyperplasia was observed at the proximal end of the device.The devices were prepared as indicated in the instructions for use (ifu).The patient was being treated for an unruptured saccular aneurysm located in the internal carotid artery, ophthalmic region, with a maximum diameter of 10mm and a neck diameter of over 4mm.Severe vessel tortuosity was also noted.Dual antiplatelet treatment was administered, though the platelet reactivity unit level was unknown.No patient complications have been reported as a result of this event.Ancillary devices: shuttle sheath.
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 received reported the patient is not experiencing any symptoms.No further actions were taken.Patient will be observed.The pipeline was not placed in a bend when it failed to open.
Event or Problem Description
Additional information received reported that the patient had previously undergoing coil embolization of the left ica ophthalmic aneurysm on (b)(6) 2023.The pipeline was placed on (b)(6) 2024 to treat residual aneurysm and multiple small ica aneurysms adjacent to the ophthalmic aneurysm.Pipeline fishmouthing was observed on imaging prior to the percutaneous transluminal angioplasty (pta).A follow-up angiogram on (b)(6) 2025 showed complete occlusion of the aneurysms and in-stent stenosis at the proximal end.
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 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: 21580133
• Report Number: 2029214-2025-00641
• Device Sequence Number: 15670563
• Product Code: OUT
• UDI-Device Identifier: 00847536036802
• UDI-Public: 00847536036802
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup,Followup
• Report Date (Section B): 05/13/2025

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 Expiration Date: 04/07/2025
• Device Model Number: PED3-027-450-16
• Device Catalogue Number: PED3-027-450-16
• Device Lot Number: B675954
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 03/27/2025; 05/01/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/22/2025; 05/13/2025
• 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
• 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: 52 YR
• Patient Sex: Female