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

Model Number	PED3-021-350-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperplasia (1906); Obstruction/Occlusion (2422)
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 the pipeline was used for an approved (on-label) indication.The device and any accessories were prepared as indicated in the ifu.The device was successfully working after the surgery.The stent full occlusion was identified by the doctor a week later during a follow up evaluation.The patient showed a good collateral circulation post occlusion on left posterior inferior cerebellar artery (pica) on rtva.There was no medical or surgical intervention needed to prevent a permanent impairment of a function.The event did not lead to or extend patient hospitalization.There was permanent injury.After the surgical processes, the angiographic results (xpercity evaluation) were favorable.The adverse results were identified on the follow up evaluation. the patient was undergoing surgery for treatment of an unruptured left vertebral artery (va) aneurysm.It was noted the patient's vessel tortuosity was normal.
Event or Problem Description
Additional information received reported that the physician mentioned the event occurred after the dsa fu at 1year.They did not specified a date: dsa fu were performed between (b)(6) 2024 /(b)(6) 2025.The morphology of each aneurysm was unknown at the time of the report.B679957- vantage ¿ lrrm ¿ pipeline vantage occluded doctor will not proceed with any interventions.Doctor mention that patient is stable under his condition and develop good collaterals.(b679957- vantage ¿ lrrm ¿ vantage occluded were implanted on (b)(6) 2024).The occlusion was first observed b679957- vantage ¿ lrrm ¿ pipe occluded - (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.
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 was received stating that for lot: b679957, there was no stent displacement issue, it was the ¿hyperplasia¿ that was stated by the doctor.No additional intervention was required or planned for a future date.The patient had no symptoms associated with the pipeline movement/migration.The raymond or roy (or other aneurysm occlusion scale) score was not specified.In this case, the pipeline was implanted to cover a left posterior inferior cerebellar artery feeder into in passage fusiform dissecting dilatation of aneurysm.The information is confirmed by the physician.
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 was received stating that the doctor believed the hyperplasia was caused by the stent.

• 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: 21575522
• Report Number: 2029214-2025-00633
• Device Sequence Number: 8431284
• Product Code: OUT
• UDI-Device Identifier: 00847536036512
• UDI-Public: (01)00847536036512(17)270115(10)B679957
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/27/2025

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: PED3-021-350-14
• Device Catalogue Number: PED3-021-350-14
• Device Lot Number: B679957
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 07/11/2025; 08/25/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/15/2025; 08/07/2025; 08/27/2025
• Date Device Manufactured: 01/16/2024
• 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: Disability
• Patient Age: 53 YR
• Patient Sex: Male