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

Model Number	PED2-375-12
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a neurovascular flow diversion procedure involving the pipeline embolization device and pipeline flex shield, the stent had migrated caudally, resulting in incomplete coverage of the neck of the aneurysm located at the left c7 terminus.The aneurysm was unruptured and saccular with a maximum diameter of 3.7 millimeters and a neck diameter of 2.5 millimeters.Angiographic imaging at a one-year follow-up showed occlusion of the anterior cerebral artery and posterior communicating artery.Dual antiplatelet treatment was administered, although the platelet reactivity unit level was not taken.The patient had a medical history of cigarette smoking, type 1 diabetes, obesity, headaches, anemia, anxiety, and arthritis.No patient complications have been reported as a result of this event.Ancillary devices: guide catheter 7 french armadillo, microcatheter medtronic phenom 027, guidewire brand, size, and lot number are not collected.
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.
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 that there were issues identified with the phenom catheter used.No cause determined.Site only stated ¿"stent had migrated caudally, post deployment.Now without full coverage of the neck of the aneurysm." site reported migration months before core-lab reported angiographically occluded branch of anterior cerebral artery and pcom.

• 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: 21968160
• Report Number: 2029214-2025-01125
• Device Sequence Number: 8123101
• Product Code: OUT
• UDI-Device Identifier: 00763000284237
• UDI-Public: 00763000284237
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 05/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PED2-375-12
• Device Catalogue Number: PED2-375-12
• Device Lot Number: B649245
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 05/10/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/20/2025
• Date Device Manufactured: 11/02/2023
• 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
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 87 KG