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	12/30/2025
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 a procedure via femoral artery access for flow diversion stent treatment of an internal carotid artery (ica) c4 segment unruptured saccular aneurysm.The aneurysm max diameter was 5.6mm and the neck diameter was 3.2mm.Patient's vessel tortuosity was moderate.It was reported that the devices were prepared and catheter was flushed as indicated in the instructions for use (ifu).During the procedure, the pipeline tip end could not be opened.Multiple attempts were made to retrieve and attempt to open, but the stent could not be opened.The system was removed and both the pipeline and the phenom 27 microcatheter were replaced to complete the procedure successfully.There was no harm or injury to the patient associate with this event.Ancillary device: navien distal access catheter.
Additional Manufacturer Narrative
Continuation of d10: product id: fg15150-0615-1s (lot: 230663927); 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.
Event or Problem Description
Additional information received.The section of the pipeline that did not open was the distal tip end.The pipeline had not been placed in a vessel bend when it failed to open.Multiple attempts were made to retrieve and reopen the device, but it still failed to open; no other additional steps or devices such as wires, catheters, or balloons were used.After removal, no damage was observed to the pipeline, and there was no resistance during delivery.Additionally, there were no problems reported with the phenom 27 microcatheter.
Additional Manufacturer Narrative
Update b5 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 was returned inside a biohazard bag and a shipping box.Visual inspection/damage location details: the distal and proximal dps restraints were intact, and the dps sleeves showed no signs of damage.Both the distal hypotube and the ptfe shrink tubing were also intact, with no signs of elongation.The distal end of the braid was not open and frayed, but the proximal end was found to be opened and frayed.The pushwire showed no bends, and there were no defects in the tip coil, distal marker, re-sheathing marker, re-sheathing pad, or proximal bumper.No other anomalies were observed.Testing/analysis: n/a.Conclusion: based on the returned device, the customer complaint was confirmed, as the distal end of the braid was not open and frayed.The cause of the failure to open could not be determined.Possible causes of failure to open include vessel tortuosity, damage to the braid, or deployment of the braid in a bend of the vessel.The customer noted that the vessel tortuosity was moderate and that the braid was not positioned in a bend, which rules these factors out as possible causes.It is possible that damage to the braid contributed to the failure to open.Such damage can occur from resheathing the braid more than twice, excessive manipulation, improper deployment techniques, pushing or pulling the delivery wire against resistance, or deploying or resheathing 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: 24026634
• Report Number: 2029214-2026-00037
• Device Sequence Number: 10719824
• Product Code: OUT
• UDI-Device Identifier: 00763000284732
• UDI-Public: (01)00763000284732(17)280814(10)D058037
• 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): 03/03/2026

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: D058037
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 02/27/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/05/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Male