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

Model Number	PED2-500-16
Medical Device Problem Codes	Material Frayed (1262); Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
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 a report that the pipeline failed to open distally.In addition, the distal tip end appeared rod-like and frayed.Resistance was encountered during advancement.The patient was undergoing surgery for treatment of an unruptured saccular aneurysm located in the left internal carotid artery c6 s egment.The landing zone artery size measured 3.9 mm distally and 4.9 mm proximally.It was noted that the patient¿s vessel tortuosity was minimal.It was reported that treatment with a flow diverter stent alone was selected.After the phenom 27 stent catheter was positioned appr opriately, a ped2-500-16 flow diverter stent was selected based on vessel measurements.During delivery, no significant resistance was encountered.After the stent was positioned, deployment was initiated at the distal m1 segment of the middle cerebral artery.App roximately 7 mm of the stent was deployed; however, the distal tip end appeared rod-like and did not open.Attempts including forward advancement and retraction, as well as resheathing and redeployment, were performed, but the distal tip end remained unopened.The stent was resheathed again, and the stent catheter was advanced as a unit.The stent was then repositioned to the distal m1 segment and redeployed.At this time, increased resistance was noted during advancement, and the distal tip end appeared frayed, with suboptimal subsequent opening.Therefore, the stent was completely resheathed and removed from the body.Another ped2-500-16 stent was selected and deployed.The stent opened well after deployment, with good apposition at both the proximal and distal ends.The guidewire formed a loop, and stent massage was performed without issue.Final anteroposterior and lateral angiography showed satisfactory results, and the procedure was concluded.Dual antiplatelet therapy (dapt) was administered.The pru level was 160.Post-procedure angiography demonstrated that the parent artery and distal vessels were patent.The pipeline device was not used for an off-label indication.The pipeline and all accessory devices were prepared in accordance with the instructions for use (ifu).The pipeline was not positioned within a bend.More than 50% of the pipeline had been deployed at the time it failed to open, and the device was resheathed more than two times.No patient symptoms were reported.Ancillary devices include a phenom 27 stent catheter.
Event or Problem Description
Additional information was received that the resistance was not very obvious.The catheter was prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.The reported statement of "rod-like" was clarified that it refers to the failure to open.The causes or contributing factors for the failure to open were not identified.The causes or contributing factors for the resistance were not identified.The causes or contributing factors for the braid damage were not identified.
Additional Manufacturer Narrative
B5: additional information added to event summary.H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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: 24579666
• Report Number: 2029214-2026-00413
• Device Sequence Number: 18730990
• Product Code: OUT
• UDI-Device Identifier: 00763000284701
• UDI-Public: (01)00763000284701(17)280814(10)D058302
• 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): 05/12/2026

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: PED2-500-16
• Device Catalogue Number: PED2-500-16
• Device Lot Number: D058302
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 04/17/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/13/2026; 05/12/2026
• 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
• Patient Age: 58 YR
• Patient Sex: Female