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	Bacterial Infection (1735); Stenosis (2263); Hemorrhagic Stroke (4417); Ischemia Stroke (4418); Respiratory Arrest (4461); Respiratory Insufficiency (4462)
Date of Event	03/11/2025
Type of Reportable Event	Death
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
It was reported that the subject experienced a ph1 hemorrhagic transformation stroke after mechanical thrombectomy with a decline in nihss from 6 to 15 following the study procedure involving the pipeline flex shield 3.25mm x 20mm.The aneurysm was located in the left hemisphere, vertebral, and was ruptured with a fusiform morphology and a maximum diameter of 3mm.The landing zone artery size was 2.2mm distal and 3.2mm proximal.The patient had a medical history of hypertension, gerd, rheumatoid arthritis, osteoarthritis, hyperlipidemia, respiratory distress, altered mental status, emesis, headache, abdominal pain, nausea, anemia, prediabetes, hydrocephalus, and acute deep vein thrombosis of the left lower extremity.No dual antiplatelet treatment was administered, and the angiographic result post-procedure was unknown.The event resulted in the patient's death on (b)(6) 2025.
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 on follow up dsa imaging obtained (b)(6) 2024, the subject had 75-95% stenosis of the posterior inferior cerebellar artery (pica).This was a branch artery that was covered by the study device during the index procedure and therefore related to the study device.
Event or Problem Description
Additional information received reported correction that the patient died on (b)(6) 2024 due to acute respiratory distress syndrome (ards).Additional reported events for this subject: pulmonary edema, bacteremia, delayed cerebral ischemia, anemia requiring transfusion, increasing right frontoparietal subdural hemorrhage, intraparenchymal hemorrhage, pica stenosis.No action or intervention was taken to address the observed stenosis.
Additional Manufacturer Narrative
B5 updated with additional information received.H6.Ime coding updated based on additional information received.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: 21798909
• Report Number: 2029214-2025-00917
• Device Sequence Number: 20910794
• 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
• Device Implanted Year: 2024
• 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): 08/06/2025

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: 04/03/2025
• Supplement Date Received by Manufacturer: 04/08/2025; 07/10/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 04/30/2025; 08/06/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 86 KG