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

Model Number	PED2-425-16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Dizziness (2194)
Date of Event	02/15/2023
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 information that a patient treated with a ped2 pipeline had complications.Patient had episode of orthostatic hyp otension when moved from bed to chair.Patient given 1 l iv fluids and symptoms resolved.It required a prolongation of existing hospitalization.The event resolved on (b)(6) 2024.The event was possibly related to study procedure.Baseline aneurysm characteristics: side (hemisphere): left.Segment of internal carotid artery (ica): c4.Location of aneurysm in vessel: sidewall.Aneurysm morphology: saccular.Maximum aneurysm diameter: 14.3mm.Aneurysm dome height: 8.6mm.Aneurysm dome width: 14.3mm.Aneurysm neck size: 5.8mm.Parent artery diameter distal to aneurysm: 2.9mm.Parent artery diameter proximal to aneurysm: 3.5mm.Ancillary devices: balt ballast 088 promary guide catheter, phenom plus catheter, phenom 027 catheter.
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 dizziness with mean arterial pressure in the 50s (low) with heart rate in the 40s.No hematoma.Hgb was low.Site did not report any specific cause for the orthostasis hypotension.

• 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: 20585110
• Report Number: 2029214-2024-02050
• Device Sequence Number: 12968680
• Product Code: OUT
• UDI-Device Identifier: 00763000284435
• UDI-Public: 00763000284435
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: 05/10/2025
• Device Model Number: PED2-425-16
• Device Catalogue Number: PED2-425-16
• Device Lot Number: B382592
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/03/2024
• Date Device Manufactured: 05/11/2022
• 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: Hospitalization
• Patient Sex: Female
• Patient Weight: 108 KG