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

Model Number	PED2-450-18
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
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
It was reported that a pipeline embolization device was used to treat an unruptured aneurysm located at c5 with amorphous morphology, a maximum diameter of 10.2 mm, and a neck diameter of 5.66 mm.The distal landing zone was 3.5mm and the proximal landing zone was 4.7mm.Severe vessel tortuosity was present.During the procedure, the middle section of the stent was slightly kinked and could not be opened, and the stent tip was riveted.After recovery and microcatheter and intermediate catheter operation, it still could not be opened.The stent was subsequently replaced, and the treatment was successfully completed.Angiography conducted post-procedure showed slow blood flow.Dual antiplatelet treatment was administered.The devices were prepared according to the instructions for use (ifu).No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
H3: device received, analysis is in progress.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 that the pipeline was not placed in a vessel bend when it failed to open.
Additional Manufacturer Narrative
Product analysis: as found condition: the pipeline flex shield device was returned for analysis inside a sealed biohazard bag and a shipping box.Damaged location details: the pipeline flex shield tip coil was in good condition.The distal and proximal dps restraints and dps sleeves were intact, with no signs of damage noted.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 were open and frayed, while the middle part of the braid was open and damaged.No bends or kinks were found on the pusher wire.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 middle¿ report could not be confirmed, as the middle part of the returned pipeline flex braid was found open but damaged.Possible causes of failure to open include severe vessel tortuosity, a damaged braid, or deployment of the braid in the vessel bend.The customer stated that the braid was not positioned in a bend, ruling out deployment of the braid in the vessel bend as a potential cause.The severe vessel tortuosity and a damaged braid could have contributed to the failure to open.However, the cause of the failure to open could not be determined.The braid can be damaged due to over-manipulation, re-sheathing more than two times, deployment technique, advancing or retracting the delivery wire against resistance, or deploying/re-sheathing the braid 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: 22891785
• Report Number: 2029214-2025-01894
• Device Sequence Number: 8851848
• Product Code: OUT
• UDI-Device Identifier: 00763000284534
• UDI-Public: (01)00763000284534(17)271015(10)B803483
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: PED2-450-18
• Device Catalogue Number: PED2-450-18
• Device Lot Number: B803483
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 08/26/2025; 10/16/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/24/2025; 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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: 62 YR
• Patient Sex: Female