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

Model Number	PED3-027-600-50
Medical Device Problem Codes	Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Codes	Aneurysm (1708); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that in august 2024, during placement of a pipeline vantage with shield technology stent, due to extreme tortuosity of the vessel the stent slipped down and only partially covered the aneurysm.The aneurysm remains widely patent as demonstrated by a ct angiogram dated (b)(6) 2025.The distal end of the device does not cover the pseudoaneurysm, it rests at the mouth of the pseudo aneurysm.The device appears to be funneling blood into the aneurysm sac, which suggests increased risk for growth and possible rupture.No patient symptoms or complications were reported with this event.The patient was undergoing surgery for treatment of a stable pseudoaneurysm of the cervical left internal carotid artery.It was not ed the patient's vessel tortuosity was extreme (severe).The underlying blood vessel diameter was nearly 6 mm.
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 that the pipeline vantage implant procedure was performed on (b)(6) 2024 at (b)(6) hospital.In (b)(6) 2025, the patient went for a follow up and was told that the pipeline vantage device migrated down the carotid to another location.The original physician left the practice so they saw another physician at (b)(6) hospital to fix the issue and resent the aneurysm.The patient was scheduled for surgery in (b)(6) 2025 however the surgery was cancelled.At that time the physician informed the patient that the pipeline vantage was recalled and they were having issues ordering the product.The patient has no symptoms or adverse effects.It was reported that the only patient guidance that the cv lifeline has regarding the recall of the pipeline vantage embolization device with shield technology is the following: for patients who have already been treated with pipeline vantage 027 and 021 devices: the treating physician should determine the need for follow-up imaging or changes to medical management based on the patient's overall health.This includes weighing the risks of dual antiplatelet therapy against potential risks for braid deformation.Resolution: answered question or provided education/documentation.
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: 24080387
• Report Number: 2029214-2026-00081
• Device Sequence Number: 18562888
• Product Code: OUT
• UDI-Device Identifier: 00847536037205
• UDI-Public: (01)00847536037205(17)270516(10)B733700
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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 Model Number: PED3-027-600-50
• Device Catalogue Number: PED3-027-600-50
• Device Lot Number: B733700
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 01/16/2026
• Date Device Manufactured: 05/16/2024
• 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: Other
• Patient Age: 52 YR
• Patient Sex: Male