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

Model Number	PED2-400-20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that the pipeline failed to open in the distal section.The patient was undergoing surgery for treatment of a saccular, unruptured large aneurysm in the left c4 with a max diameter of 10 mm and a 5 mm neck diameter.The landing zone was 3.72 mm distally and 4.07 mm proximally.It was noted the patient's vessel tortuosity was minimal.The angiographic result post procedure showed normal blood flow in the parent artery and distal vessels.It was reported that a large aneurysm of the left internal carotid artery c4 segment was treated with a dense mesh pipeline stent im plantation.A pipeline dense mesh stent was selected for implantation.The phenom27 stent catheter was passed through the guidewire to the m1 segment, the guidewire was withdrawn, the delivery sheath was pressed against the phenom27 hub port, and the stent was delivered to the m1 segment.After the stent catheter came out, the tip end was opened.The stent tip end was opened about 5mm, but it could not be fully opened.When the stent was deployed to 7-8mm, it was found that the stent still could not be opened.The physician locked the y valve, pushed and pulled it several times, but it still could not be opened.The physician loosened the y valve, retrieved the stent, and tried to open it again twice, but it still could not be opened.Considering that there might be product quality issues with the stent and the catheter itself, we considered replacing the stent and selected another pipeline.After full hydration, the new stent was deployed again.The surgery was then ended and completed successfully.The pipeline was not positioned in a bend, the pipeline had been deployed less than 50% when it failed to open.The pipeline was resheathed less than or equal to 2 times.No additional steps or other devices were required to open the pipeline.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu) and was not used off-label.No patient symptoms or complications were associated with this event.Ancillary devices include a phenom 27 catheter and an additional pipeline.
Event or Problem Description
Additional information received reported there were no other additional steps or devices used to open the pipeline.The cause of the pipeline failure to open was not determined.
Additional Manufacturer Narrative
B5 updated with additional information received.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
Product analysis #(b)(4): equipment used: vis (m-78210) as found condition: the pipeline flex device was returned within a shipping box and a plastic bio-pouch.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).The pipeline flex braid middle segment was found damaged.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 and the patient's vessel tortuosity was minimal, it is likely that 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.

• 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: 22907631
• Report Number: 2029214-2025-01906
• Device Sequence Number: 8018261
• Product Code: OUT
• UDI-Device Identifier: 00763000284367
• UDI-Public: (01)00763000284367(17)270411(10)B717227
• 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): 11/03/2025

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: PED2-400-20
• Device Catalogue Number: PED2-400-20
• Device Lot Number: B717227
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 10/06/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/26/2025; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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: 65 YR
• Patient Sex: Male