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

Model Number	PED2-300-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Paresis (1998); Dysphasia (2195); Obstruction/Occlusion (2422); Shaking/Tremors (2515); Nervous System Injury (2689)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id ped2-300-16 (b715031); product id ped2-350-12 (d026883).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 three pipeline vantage stents implanted to treat a 2.8mm unruptured saccular basilar artery aneurysm 5 days prior.No device malfunction was reported associated with this event.Patient's vessel tortuosity was normal.Dual antiplatelet treatment (dapt) was administered.It was reported that around 2000, the patient presented with dysarthria and weakness in all 4 extremities.By the time neurology had assessed, the patient's symptoms had almost resolved except for slight dysarthria and hand paresthesia.The next morning at 0700, the neurological exam was normal.However, around 0900, the patient again experienced right upper extremity (rue) weakness with anarthria as well as tremors in left upper extremity (lue) and jaw.By 0930, the patient also had moderate dysarthria without aphasia - comprehension and naming were normal.Tremors did not appear clonic in nature and stopped when holding patient's hand; seizure seemed unlikely.Repeat computed tomography (ct) was performed with no observation of stroke or hemorrhage.Based on the available information the care team considered the patient's fluctuating neurological symptoms following basilar stent placement were most likely due to perfusion deficit related to occlusion of the small perforating arteries by the stent construct.The patient's status improve after the morning.Additional imaging (mri and eeg) was planned and the patient agreed to prophylactic intravenous (iv) heparin and partial bolus.
Additional Manufacturer Narrative
B5 updated with 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.
Event or Problem Description
Additional information received reported the cause of the event was considered to be most likely due to occlusion of the small perforator arteries by the pipeline construct.The patient's condition is consistently improving.

• 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: 24513625
• Report Number: 2029214-2026-00363
• Device Sequence Number: 18564904
• Product Code: OUT
• UDI-Device Identifier: 00763000283995
• UDI-Public: (01)00763000283995(17)280107(10)D008702
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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
• Report Date (Section B): 04/02/2026

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: PED2-300-18
• Device Catalogue Number: PED2-300-18
• Device Lot Number: D008702
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/02/2026
• Date Device Manufactured: 01/07/2025
• 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: Required Intervention; Other
• Patient Sex: Unknown