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

Model Number	PED3-027-450-20
Medical Device Problem Codes	Collapse (1099); Structural Problem (2506); Activation, Positioning or Separation Problem (2906); Activation Failure (3270)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Ischemia Stroke (4418)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pipeline vantage with shield technology was involved in a neurovascular flow diversion procedure for an unruptured saccular aneurysm located in the internal carotid artery.Two days post-procedure, the patient experienced stroke-like symptoms.Imaging revealed that the proximal end of the stent had collapsed and foreshortened, obstructing normal blood flow, which caused a stroke.There was a failure to open in the proximal and middle sections of the pipeline, which was positioned in a bend in the middle section.The pipeline was resheathed more than two times, and balloon angioplasty was required to open it.The vessel tortuosity was noted as severe.The angiographic result immediately post-procedure appeared fine.The pipeline was not removed from the patient, and full wall apposition was achieved.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a phenom 27 microcatheter and a non-medtronic 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.
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 seems to be inproving and getting better.The patient is receiving post stroke care.Balloon angioplasty was performed in the initial procedure.Then two days after with second intervention while treating the stroke.Failure to open occured during the initial procedure.
Event or Problem Description
Additional information received reported balloon angioplasty was completed to open up the collapsed vantage.
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.
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: 20762568
• Report Number: 2029214-2024-02182
• Device Sequence Number: 20979240
• Product Code: OUT
• UDI-Device Identifier: 00847536036826
• UDI-Public: (01)00847536036826(17)270311(10)B703735
• 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
• 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,Followup
• Report Date (Section B): 08/18/2025

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: PED3-027-450-20
• Device Catalogue Number: PED3-027-450-20
• Device Lot Number: B703735
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 12/19/2024; 01/16/2025; 08/18/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/14/2025; 01/29/2025; 08/18/2025
• Date Device Manufactured: 03/11/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female