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 Codes	Headache (1880); Visual Disturbances (2140); Numbness (2415); Ischemia Stroke (4418)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id: ped3-027-450-12 (b708791); implant date: n/a; explant date: n/a.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.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, the first device (4.5x16) foreshortened upon removal of the microcatheter, necessitating the placement of a second device (4.5x12).The device was said to have migrated due to the foreshortening.The pipeline had been implanted in the intended location with wall apposition achieved.Post-operatively, the patient experienced vision issues, numbness, and headaches.An mri revealed a focal low density with loss of gray-white differentiation in the lateral left basal ganglia subsinular region.The aneurysm was located in the left internal carotid artery, was unruptured, and had a saccular morphology with a maximum diameter of 4.5 millimeters and a neck diameter of 4mm.The patient's vessel tortuosity was moderate.Dual antiplatelet treatment was administered, and the angiographic result showed successful placement of the second device.The patient remained alive with injury.Ancillary devices include a ballast sheath, navien 058 guide catheter, and phenom 27 microcatheter.
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 patient was still having symptoms.No actions/interventions were taken to resolve the adverse events.The cause of the foreshortening was not determined.The pipeline had not been placed in a vessel bend.

• 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: 21314494
• Report Number: 2029214-2025-00291
• Device Sequence Number: 8243913
• Product Code: OUT
• UDI-Device Identifier: 00847536036802
• UDI-Public: 00847536036802
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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: 02/04/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 02/24/2025
• 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: 2029214-01-31-2025-001-R
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 73 KG