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

Model Number	PED2-425-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
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
Medtronic received a report that a pipeline patient experienced post procedure stenosis.It was unknown if the reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for an unruptured left hemisphere segment of ica c4 aneurysm in the vessel sidewall with a saccular morphology.Aneurysm dimensions: max diameter 5.2 mm and neck diameter 4.7 mm.Landing zone (artery size): distal 3.8 mm and proximal 4.2 mm.The vessel tortuosity was unknown.Dsa at 180-day reported parent artery stenosis >50% per site reported data.Post procedure implant imaging resulted no stasis at the end of the procedure.Complete neck coverage was achieved at the end of the procedure.The rayment and roy rating at the end of the procedure was class 3.It was unknown if there were any patient symptoms or complications associated with this event.Ancillary devices: guide catheter infinity 088, navien 058 microcatheter phenom 027, aristotle 18.
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 180 follow up aneurysm occlusion status r class 1.
Event or Problem Description
Additional information received reported no intervention been reported for parent artery stenosis by the site, additionally the site has not confirmed any adverse patient event.
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's 6 month imaging from on (b)(6) 2024 showed intimal hyperplasia within the mi d-ophthalmic segment of the ica resulting in moderate in-stent stenosis without flow limitation.Interval improvement was seen at the patient's 1-year imaging on (b)(6) 2024.The parent artery stenosis was updated from >50% to less than 50%.
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 corelab review of 180-day follow up visit dsa on (b)(6) 2024 reported parent artery stenosis 51-75%.However, the one year dsa imaging report by (b)(6) reported improvement to 26-50% (dsa date (b)(6) 2024).
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 FLEX W/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: 19229655
• Report Number: 2029214-2024-00832
• Device Sequence Number: 5919467
• Product Code: OUT
• UDI-Device Identifier: 00763000284428
• UDI-Public: 00763000284428
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/03/2025

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 Expiration Date: 09/07/2025
• Device Model Number: PED2-425-14
• Device Catalogue Number: PED2-425-14
• Device Lot Number: B443195
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 04/22/2024; 05/13/2024; 10/23/2024; 12/09/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/02/2024; 06/05/2024; 11/15/2024; 01/03/2025
• Date Device Manufactured: 09/08/2022
• 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: Life Threatening
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 64 KG