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

Model Number	PED2-350-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	08/24/2023
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 that patient experienced visual field defect with an onset date of (b)(6).This event resulted in new hospitalization from (b)(6) 2023 to (b)(6) 2023.This adverse event (ae) did not result in any treatment, blood transfusion, percutaneous intervention, or surgical procedure.The outcome status is recovered/resolved with an outcome date of (b)(6) 2023.Ae possibly related to the disease under study.Ae did not result in a new or worsening of existing neurological deficit.Ae did not result from a device deficiency.The patient reported that her right upper vision went gray temporarily.Normal computerized tomography (ct) head without contrast, restarted brilinta 60mg, neurology cleared patient for discharge.The site assessed this event did not lead to congenital anomaly, death, disability, or medical intervention and was not considered life-threatening.The site assessed this event as possibly related to the study procedure and causally related to the study device.Aneurysm details:  side (hemisphere): right specify segment of ica: c6 location of aneurysm in vessel: sidewall aneurysm morphology: saccular maximum aneurysm diameter: 8.5mm aneurysm dome height: 6mm aneurysm dome width: 5mm aneurysm neck size: 3.8mm parent artery diameter distal to aneurysm: 3.2mm parent artery diameter proximal to aneurysm: 3.7mm post implant - specify stasis at the end of the procedure: no stasis post implant - complete neck coverage at the end of the procedure: y post implant - indicate aneurysm occlusion (raymond and roy) at the end of the procedure: class 3 additional information was received updating the description from visual field defect to "amaurosis fugox.".

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19221809
• Report Number: 2029214-2024-00818
• Device Sequence Number: 20589534
• Product Code: OUT
• UDI-Device Identifier: 00763000284145
• UDI-Public: 00763000284145
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 05/01/2024

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: 12/13/2024
• Device Model Number: PED2-350-12
• Device Catalogue Number: PED2-350-12
• Device Lot Number: B312179
• 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: 04/18/2024
• Initial Report FDA Received Date: 05/01/2024
• Date Device Manufactured: 12/14/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 82 KG