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	Hematoma (1884); Swelling/ Edema (4577)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that a pipeline patient experienced a bilateral le edema with no evidence of dvt.A hematoma was identified in the left wrist with 1.8 mm mass found adjacent to the left radial artery.Some swelling in the left wrist was also noted.The arterial line was placed in the left wrist for the index procedure.The patient was being treated for a left c4 ica aneurysm.The access vessel was the femoral right rist was not used.The adverse event (ae) did not result in hospitalization or any other actions taken/treatment.The patient was recovering/resolving.The adverse event (ae) was not related to the disease under study.The ae did not result from a device deficiency.The study device was successfully implanted in the subject.Ancillary devices: guide catheter infinity 088.
Additional Manufacturer Narrative
Continuation of d10: product id: (unknown); product id: (unknown).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
Additional information received reported the event was possibly related to antiplatelet medication and study procedure.Baseline aneurysm characteristics: location of aneurysm in vessel: sidewall.Aneurysm morphology: saccular.Maximum aneurysm diameter: 6.7mm.Aneurysm dome height: 4.8mm.Aneurysm dome width: 4.8mm.Aneurysm neck size: 4.8mm.Parent artery diameter distal to aneurysm: 3.9mm.Parent artery diameter proximal to aneurysm: 4.2mm.
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.
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 bilateral lower extremity edema.Cec adjudicated as possibly related to the procedure.

• 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: 20417319
• Report Number: 2029214-2024-01831
• Device Sequence Number: 8209193
• 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: 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): 03/25/2025

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: PED2-425-16
• Device Catalogue Number: PED2-425-16
• Device Lot Number: B621497
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 12/07/2024; 02/26/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 01/02/2025; 03/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White