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

Model Number	PED2-500-25
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
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 a report that the surgeon used a ped-5.0-25 stent to treat a left internal carotid artery ophthalmic artery aneurysm.The stent was delivered to the m2 segment of the internal carotid artery.After opening in the straight segment, it pulled against the rivet at the end of the internal carotid artery.At the neck of the aneurysm, repeated pushed and pulled failed to open.The surgeon retrieved and deployed the stent again, but still failed to open.Then, the stent was replaced with a 4.75-25 stent, and the surgery proceeded smoothly.No patient symptoms or further complications were reported as a result of this event.The device and any accessories were prepared as indicated in the ifu.The pipeline was used for an approved on-label) indication.The patient was undergoing surgery for treatment of a saccular, unruptured ophthalmic artery aneurysm with a max diameter of 8 mm and a 6 mm neck diameter.The landing zone was 3.7mm distally and 5.0mm proximally.It was noted the patient's vessel tortuosity was severe.Dual antiplatelet therapy (dapt) was administered.The angiographic result post procedure was right internal carotid artery ophthalmic artery aneurysm.
Additional Manufacturer Narrative
Product analysis: ¿ as found condition: the pipeline flex device was returned within a shipping box, a plastic bio-pouch, an open pipeline flex inner pouch, and a dispenser coil.¿ visual inspection/damage location details: no bends or kinks were found with the pipeline flex pusher.The pipeline flex pusher re -sheathing pad, sleeves, and tip coil were found to be in good condition.The pipeline flex braid was returned already detached from the pusher.Therefore, the proximal and distal ends of the braid could not be identified.Both ends of the pipeline flex braid were found open and damaged (frayed).¿ testing/analysis: none ¿ conclusion: based on the device analysis and reported information, the customer¿s ¿failure/incomplete open distal¿ report could not be confirmed as both ends of the pipeline flex braid were found open.Possible causes of ¿failure/incomplete open distal¿ include patient vessel tortuosity, damaged braid, or user deploys braid in vessel bend.As the braid was not deployed in a bend, it is likely that the patient¿s severe vessel tortuosity and the damage found with the braid contributed to the failure to open.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received.The cause of the failure to open was not determined.The failure occurred in the distal section of the pipeline.The device had not been placed in a vessel bend when the issue was observed.No additional steps or adjunctive devices, such as resheathing, wire/catheter manipulation, or balloon assistance, were attempted to open the pipeline.

• 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: 22945564
• Report Number: 2029214-2025-01951
• Device Sequence Number: 9892952
• Product Code: OUT
• UDI-Device Identifier: 00763000284732
• UDI-Public: (01)00763000284732(17)271016(10)B804298
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• 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,Followup
• Report Date (Section B): 11/24/2025

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: PED2-500-25
• Device Catalogue Number: PED2-500-25
• Device Lot Number: B804298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 09/03/2025; 10/28/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/04/2025; 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 50 KG