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

Model Number	PED2-325-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a history of cigarette smoking, anemia, anxiety, premature ventricular contractions, a transient ischemic attack, and an aneurysm of the cavernous portion of the left internal carotid artery experienced an adverse event of anesthesia during a c-section.The aneurysm was located in the left hemisphere c4 sidewall, was unruptured, and had a saccular morphology with a maximum diameter of 3.4 millimeters and a neck diameter of 3.0 millimeters.The pipeline flex shield device was implanted, with a distal landing zone artery size of 3.3 millimeters and a proximal size of 3.4 millimeters.It was noted that during a one-year follow-up, the raymond and roy classification was reported as class 3, whereas it was previously reported as class 1 at a six-month cta imaging follow-up.The site was queried to confirm the class 3 status.The device remained implanted with complete wall apposition, and no device deficiencies or adverse events were reported.The patient had no symptoms, and the modified rankin score was 0 at one year.The patient outcome was reported as alive with no 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.
Additional Manufacturer Narrative
Mdr decision corrected to not reportable.No additional supplemental reports are required unless additional information received indicates a reportable event.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
It was reported that a patient with a history of cigarette smoking, anemia, anxiety, premature ventricular contractions, a transient ischemic attack, and an aneurysm of the cavernous portion of the left internal carotid artery (l-ica) experienced an adverse event.The aneurysm was located in the left hemisphere c4 sidewall, was unruptured, and had a saccular morphology with a maximum diameter of 3.4 millimeters and a neck diameter of 3.0 mm.The pipeline flex shield device was implanted, with a distal landing zone artery size of 3.3 millimeters and a proximal size of 3.4 mm.It was noted that during a one-year follow-up, the raymond and roy classification was reported as class 3, whereas it was previously reported as class 1 at a six-month cta imaging follow-up.The site was queried to confirm the class 3 status.The device remained implanted with complete wall apposition, and no device deficiencies or adverse events were reported.The patient had no symptoms, and the modified rankin score (mrs) was 0 at one year.The patient outcome was reported as alive with no injury.Mdr decision corrected to not reportable.No additional supplemental reports are required unless additional information received indicates a reportable event.

• 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: 21200582
• Report Number: 2029214-2025-00175
• Device Sequence Number: 8599289
• Product Code: OUT
• UDI-Device Identifier: 00763000284060
• UDI-Public: 00763000284060
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 02/12/2025

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: 06/16/2025
• Device Model Number: PED2-325-14
• Device Catalogue Number: PED2-325-14
• Device Lot Number: B401921
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/12/2025
• Date Device Manufactured: 06/17/2022
• 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: Life Threatening
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 58 KG