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	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a pipeline flex with shield that failed to open.The patient was undergoing the procedure for flow diverter treatment of left carotid artery unruptured saccular aneurysm.The aneurysm max diameter was 4mm and the aneurysm neck diameter was also 4mm.The distal landing zone was 4mm; the proximal landing zone was 5mm.Vessel tortuosity was minimal.Dual antiplatelet treatment (dapt) was administered.It was reported the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu).The pipeline was delivered to the ipsilateral m1 segment and deployment was initiated.Approximately 7-8mm of the pipeline stent tip was exposed and the surgeon waited about 10 seconds but the pipeline tip failed to open.The surgeon deployed up to about 12mm and the stent tip still failed to open.The surgeon tried to maneuver the pipeline: resheathed and redeployed, shaking, push and pull, but the tip of the stent could not be opened.The pipeline was then removed from the patient's body and still could not open in vitro so the pipeline was replaced to complete the procedure successfully.There was no harm or injury to the patient associated with this event.
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 was received that the cause of the pipeline failure to open was not determined.The distal section of the pipeline did not open.The pipeline was not placed in a vessel bend when it failed to open.
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 shield embolization device was returned for analysis within shipping box; within a plastic bio-pouch; within an opened pipeline flex shield inner pouch; and within a dispenser coil.Damage location details: no bent or kink was found with pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No defects were found with the tip coil, distal marker, re-sheathing marker, pads or with the proximal bumper.The braid was returned already detached from the pusher; therefore, the proximal and distal ends could not be identified.The pipeline flex shield braid was found fully opened and damaged.No other anomalies were observed.Testing/analysis: n/a.Conclusion: based on the analysis findings, the pipeline flex shield could not be confirmed to have failure /incomplete open at distal as the device was resheated.In addition, the proximal and distal ends could not be identified.The pipeline flex shield braid was found fully opened and damaged.However, the root cause for damage could not be determined.Possible causes of ¿failure/incomplete open¿ include vessel tortuosity, damaged braid, and deployment of the braid in the vessel bend.The customer indicated that vessel tortuosity was minimal and the pipeline was not placed in a vessel bend.Which eliminates these factors out as potential causes.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: 24160982
• Report Number: 2029214-2026-00141
• Device Sequence Number: 21114417
• 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: 2026
• Device Explanted Year: 2026
• 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): 04/01/2026

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: 01/20/2026
• Supplement Date Received by Manufacturer: 01/26/2026; 03/20/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/18/2026; 04/01/2026
• 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: 54 YR
• Patient Sex: Male