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

Model Number	PED2-325-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Intracranial Hemorrhage (1891); Vasoconstriction (2126); Cognitive Changes (2551)
Date of Event	12/06/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Continuation of d10: product id: ped2-325-20 (b621488).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 information regarding a patient who had two pipelines of the same model/lot implanted who had post-operative complications.It was reported that the two pipeline flex with shield stents were implanted on (b)(6) 2024.No device malfunction or intraoperative issue was reported.On (b)(6) 2024, the patient was hospitalized after experiencing fever and progressive decline in mental status.Imaging results were suggestive of concern for cerebral vasospasm associated with subarachnoid hemorrhage (sah) in evolution.The patient underwent a procedure for intraarterial vasodilator (verapamil 20mg) internal carotid artery (ica) infusion with mild improvement and was monitored.It was considered likely that vasospasm caused the symptoms of fever and similar symptoms to pneumonia and septic shock.The patient outcome was noted as "recovering/resolving." the event required patient hospitalization and intervention but was not life-threatening and did not result in patient disability.Site assessment concluded the events were possible related to the patient disease under study and/or the index procedure but not related to the implanted pipelines or accessory devices.
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 event was causally related to the disease under study.The site was queried to confirm if multiple devices were used.Available source document only mentions one study device implantation.
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 event became fatal on (b)(6) 2024.Symptomatic vasospasm pdo 5, 8, dci on ct pod 18, death severe adverse event criteria although not immediate cause of death, the vasospasm and dci may have contributed to prolonged intubation and ards.

• 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: 21093492
• Report Number: 2029214-2025-00066
• Device Sequence Number: 21015727
• Product Code: OUT
• UDI-Device Identifier: 00763000284091
• UDI-Public: (01)00763000284091(17)260905(10)B621488
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2025

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: 09/05/2026
• Device Model Number: PED2-325-20
• Device Catalogue Number: PED2-325-20
• Device Lot Number: B621488
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 01/14/2025; 07/16/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/05/2025; 08/13/2025
• Date Device Manufactured: 09/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Death; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White