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

Model Number	PED2-500-18
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the pipeline did not open.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the left internal carotid artery cavernous sinus segment with a max diameter of 5.37 mm and a 4.42 mm neck diameter.The landing zone was 4.47 mm distally and 4.93 mm proximally.It was noted the patient's vessel tortuosity was moderate.It was reported that while using a phenom 27 microcatheter guided by a 0.014 neuro guidewire, it was pushed to the upper m2 segment of the middle cerebral artery.A pipeline stent was delivered through the phenom 27 to the straight segment of the m1.Upon retrieving the microcatheter in situ to deploy the stent tip, it was observed that the stent tip did not open.Additional length was deployed, but the stent still did not fully open.Applying tension did not resolve the issue.A distal access catheter was pushed, and the stent was retrieved and redeployed, but the tip still did not fully open.Attempts were made to retrieve the entire stent to the internal carotid artery and adjust the tension level, but the stent tip still did not open properly.The stent was subsequently retrieved entirely and removed from the body.A new stent was used instead, and the procedure was successfully completed.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Pipeline was not used off-label.No patient symptoms or complications were associated with this event.Additional information was received stating that the cause of the event was not determined.The pipeline had not been placed in a vessel bend when it failed to open.In an additional attempt to open the pipeline, the intermediate catheter was pushed to go upper.Ancillary devices include a phenom 27 microcatheter and a 0.014 neuro guidewire.
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 there was no issue with the phenom catheter.
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.
Additional Manufacturer Narrative
Product analysis: 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.No damage was found with the pipeline flex pusher resheathing pad or sleeves.The pipeline flex pusher tip coil was found bent.The pipeline flex braid was returned detached from the pusher; therefore, the proximal and distal ends could not be identified.Both ends of the pipeline flex braid were found open, but damaged (frayed).The middle of the pipeline flex braid was found damaged (kinked).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.It was noted the patient's vessel tortuosity was moderate and the pipeline was not positioned in a bend.Therefore, 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: 23003248
• Report Number: 2029214-2025-01978
• Device Sequence Number: 9619396
• Product Code: OUT
• UDI-Device Identifier: 00763000284718
• UDI-Public: (01)00763000284718(17)280427(10)D035452
• 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): 11/11/2025

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: PED2-500-18
• Device Catalogue Number: PED2-500-18
• Device Lot Number: D035452
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 09/10/2025; 10/16/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/07/2025; 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• 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: 57 YR
• Patient Sex: Female