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 Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a pipeline that failed to open.The patient was undergoing a procedure to treat an ophthalmic artery unruptured saccular aneurysm.The aneurysm max diameter was 5mm and the neck diameter was 4mm.Vessel tortuosity was normal.Dual antiplatelet treatment (dapt) was administered.It was reported that the pipeline and all accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).After measurements were take and the 5 x 18 pipeline was selected, the phenom 27 microcatheter was delivered in place.Deployment of the pipeline was initiated but the tip failed to open.Repeated attempts to retrieve and redeploy the pipeline were done but the pipeline tip still failed to open.The pipeline was retrieved along with the phenom 27 microcatheter.The pipeline was examined in vitro and the tip of the stent was frizzy and slightly damaged.Both the pipeline and phenom microcatheter were replaced to complete the procedure successfully.There was no harm or injury to the patient associated with this event.Post procedure angiography showed blood retention in the aneurysm.
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s (lot: 229655205); implant date n/a; explant date n/a.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 the pipeline did in the distal section.It was placed in a straight segment when it failed to open.The pipeline was resheathed 3 times.There was no resistance during delivery or retrieval of the pipeline.
Additional Manufacturer Narrative
Product analysis #(b)(4):equipment used: video inspection system (m-81805), ruler (m-83361), camera (panasonic lumix dmc-zs5) as found condition: the pipeline flex shield device and phenom 27 catheter were returned for analysis inside a sealed biohazard bag and a shipping box.Damaged location details: the pipeline flex shield¿s tip coil is in good condition.The distal and proximal dps restraints and dps sleeves were found intact, with no signs of damage.No defects were found on the re-sheathing marker and re-sheathing pad.The distal hypotube and ptfe shrink tubing were intact, with no signs of elongation or damage.The braid¿s distal and proximal ends are open and frayed.The middle part of the braid was fully open.The pusher wire was kinked at ~89.5cm from the distal tip.No other anomalies were found.Testing/analysis: n/a conclusion: based on the reported information and device analysis, the customer¿s ¿failure/incomplete to open at distal¿ complaint could not be confirmed, as the distal end of the returned pipeline flex shield braid was found to be open and frayed.However, the cause of the failure to open could not be determined.Possible causes include vessel tortuosity, the user deploying the braid in the vessel bend, or a damaged braid.In this event, the customer reported that the vessel tortuosity was normal, and the braid was placed in a straight segment, ruling out vessel tortuosity and the user deploying the braid in a vessel bend as potential causes.Therefore, a damaged braid could have contributed to the failure to open complaint.The braid can be damaged due to over-manipulation, re-sheathing more than two times, improper deployment technique, delivery/retracting delivery wire against resistance, or deployment or re-sheathing of the delivery wire against resistance.However, the cause of the braid damage could not be determined.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: 22631320
• Report Number: 2029214-2025-01707
• Device Sequence Number: 7994840
• Product Code: OUT
• UDI-Device Identifier: 00763000284732
• UDI-Public: (01)00763000284732(17)270819(10)B776387
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2025

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: B776387
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 08/03/2025; 09/12/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/29/2025; 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Unknown