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

Model Number	PED2-425-16
Medical Device Problem Codes	Unintended Movement (3026); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
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
Medtronic received information regarding a pipeline flex with shield that had movement during deployment and then failed to open.The patient was undergoing a procedure for flow diversion treatment of a left internal carotid artery (ica) c6 segment unruptured saccular aneurysm.The aneurysm max diameter was 3.5mm and the neck diameter was 2.7mm.Vessel tortuosity was moderate.Dual antiplatelet treatment (dapt) was administered.It was reported that the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu).During deployment, the pipeline stent slipped to the c5.The stent was retrieved and pushed to go upper using a radiopaque guidewire.After delivering the pipeline to the intended position deployment was initiated again but the tip end of the pipeline could not be opened.Pushing and pulling was tried, but was not successful in opening the stent.The pipeline was removed and replaced to complete the procedure successfully.There was no harm or injury to the patient associated with this event.Post-procedure angiography of the aneurysm showed good contrast retention in the aneurysm with clear vasculature shown in both frontal and lateral views.
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 stating that only one pipeline device was used when movement occurred.No friction was encountered during delivery or positioning, and the device did not jump during deployment.Upon retracting the microcatheter, it was found that the pipeline could not be opened.The section of the pipeline that did not open was the distal end.The pipeline was located in a straight section when it failed to open.
Additional Manufacturer Narrative
H2/h3: product analysis ¿ as found condition: the pipeline flex shield was returned inside the inner pouch, biohazard bag, and 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 and proximal ends of the braid were found open 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's report of "failure to open at the distal" was not confirmed, as the distal end of the braid was opened 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 indicated that the vessel tortuosity was moderate and the braid was positioned in the straight vessel, which rules them out as possible causes.In this event, the damaged braid contributed to the failure to open.Such damage can occur from over-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.The customer's report of "movement during deployment" could not be confirmed.The cause could not be determined.Possible causes include vasospasm, vessel tortuosity, and high-force delivery.H6: coding update based on analysis.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: 24094294
• Report Number: 2029214-2026-00090
• Device Sequence Number: 16034375
• Product Code: OUT
• UDI-Device Identifier: 00763000449278
• UDI-Public: (01)00763000449278(17)280905(10)D063009
• 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): 05/05/2026

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: PED2-425-16
• Device Catalogue Number: PED2-425-16
• Device Lot Number: D063009
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 01/20/2026; 04/23/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/12/2026; 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2025
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 66 KG