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

Model Number	PED2-375-20
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an aneurysm blood flow diversion dense mesh stent implantation procedure, the ped2-375-20 stent tip failed to open smoothly after deployment of about 8mm.The aneurysm was located at the right posterior communicating segment of the internal carotid artery, unruptured, with a saccular morphology, a maximum diameter of 5.36 mm, and a neck diameter of 4.43 mm.The access vessel was the femoral artery with a diameter of 3.98 mm.Landing zone: distal: 3.21 mm and proximal: 3.74 mm.Vessel tortuosity was minimal.The stent tip was fusiform and could not open normally even after a second attempt.The ped2 stent and phenom27 catheter were removed and replaced with new ones to complete the surgery successfully.Dual antiplatelet treatment was administered, and the angiographic result post-procedure was normal.The catheter was flushed as indicated in the instructions for use.No patient comp lications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s (lot: 229103330); product type.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 that the cause of the failure to open/pipeline damage was not determined.The pipeline had not been positioned in a vessel bend when it failed to open.They had pushed the intermediate catheter to go upper in an attempt to open the pipeline.There was no damage or issue with the phenom catheter.

• 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: 21593388
• Report Number: 2029214-2025-00655
• Device Sequence Number: 8349823
• Product Code: OUT
• UDI-Device Identifier: 00763000284275
• UDI-Public: 00763000284275
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: PED2-375-20
• Device Catalogue Number: PED2-375-20
• Device Lot Number: B774080
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/21/2025
• Date Device Manufactured: 08/14/2024
• 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: 56 YR
• Patient Sex: Male