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

Model Number	PED2-350-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Numbness (2415); Speech Disorder (4415); Ischemia Stroke (4418)
Date of Event	12/23/2024
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that following the placement of a pipeline flex shield 3.50mm x 20mm for a left superior hypothoseal saccular aneurysm, the patient experienced numbness on the right side, transient episodes of right-sided hand weakness, speech issues, right hand numbness and weakness, and right facial numbness.Magnetic resonance imaging (mri) revealed multiple t2 hyperintense foci throughout the left cerebral hemisphere with post-contrast enhancement, consistent with non-ischemic cerebral enhancing lesions (nice event).The patient was administered dual antiplatelet treatment with plavix and aspirin, as genetic testing indicated responsiveness.Steroids were initiated as an intervention.Follow-up mri showed a decrease in size and enhancement of multiple focal flair lesions.The angiographic result post-procedure indicated that everything appeared satisfactory following the placement.The device remains implanted and in service.Additional information received reported that the patient went without incident on (b)(6) 2024 but once off steroids ended up in er with stroke symptoms this concluded with diagnosis of non-ischemic lesions located in 4 places likely due to searing of the stent during placement.Follow up ct and mri done seeing flares or lesions were reduced post procedure.Procedure date was (b)(6) 2024 first emergency room visit on (b)(6) 2024 with another er visit on (b)(6) 2024 both times presented with stroke-like symptoms of facial drooping and slurred speech.

• 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: 21158464
• Report Number: 2029214-2025-00136
• Device Sequence Number: 18035675
• Product Code: OUT
• UDI-Device Identifier: 00763000284183
• UDI-Public: 00763000284183
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2025

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: 07/17/2026
• Device Model Number: PED2-350-20
• Device Catalogue Number: PED2-350-20
• Device Lot Number: B596252
• 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: 01/07/2025
• Initial Report FDA Received Date: 01/15/2025
• Date Device Manufactured: 07/18/2023
• 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: Life Threatening
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 60 KG