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

Model Number	PED3-021-250-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Vomiting (2144); Loss of consciousness (2418); Hemorrhagic Stroke (4417)
Date of Event	05/23/2025
Type of Reportable Event	Death
Event or Problem Description
Medtronic received a report that the patient was undergoing treatment of an amorphous, unruptured left vertebral artery aneurysm with a max diameter of 4.5mm and a 3.9mm neck diameter.It was noted the patient's vessel tortuosity was severe.The landing zone was 1.7mm distally and 2mm proximally.Dual antiplatelet treatment (dapt) was administered.The pru level was unknown.It was reported that the access past the aneurysm was not able to be achieved from the left side.Attempted coil placement but coils would not stay in the aneurysm.The physician decided to cross from the right vertebral artery and deploy a pipeline vantage.The device was deployed without incident.After the procedure was concluded, the patient vomited and became unresponsive in recovery.A ct scan was conducted, and a hemorrhage was seen.External ventricular drain (evd) was placed, and the patient became responsive.Approx 30 mins later, the patient became unresponsive again and the pupils were fixed.The angiographic result post procedure showed good apposition, and no complications noted.The pipeline used for an indication that is not approved (off-label).The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The patient deceased.
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 catheter was an sl10 j shape.Coils attempted were fc-3.5-6, stryker tetra 4x8.
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: 22132599
• Report Number: 2029214-2025-01293
• Device Sequence Number: 8447834
• Product Code: OUT
• UDI-Device Identifier: 00847536036239
• UDI-Public: 00847536036239
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: PED3-021-250-14
• Device Catalogue Number: PED3-021-250-14
• Device Lot Number: B673035
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/26/2025
• Date Device Manufactured: 12/21/2023
• 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: Death
• Patient Age: 53 YR
• Patient Sex: Female