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

Model Number	PED2-500-35
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a medium-sized, wide-necked, unruptured ophthalmic artery aneurysm with saccular morphology was identified, and a pipeline dense mesh stent was planned for implantation using a ricoton 6f-115 intermediate catheter and a phenom 27 microcatheter, which was advanced to the m2 segment.After full hydration, the pipeline dense mesh stent was delivered into the microcatheter, and the distal end was deployed at the straight segment of m1.Despite repeated attempts and efforts such as pushing the delivery wire forward, the distal end of the stent failed to open.The pipeline was removed and replaced.Dual antiplatelet treatment was administered, and the platelet reactivity unit level was normal.Angiographic results post-procedure confirmed the presence of the ophthalmic artery aneurysm.The pipeline dense mesh stent was resheathed more than twice and removed with the microcatheter.No patient complications have been reported as a result of this event.The aneurysm max diameter was 10mm, and the neck diameter was 6mm.The landi ng zone was 4.5mm distal and 5.1mm proximal.The patient's vessel tortuosity was minimal.The access vessel was the femoral artery, which was 2mm in diameter.The pipeline was not positioned in a bend and less than 50% had been deployed when it failed to open.No additional steps were required to open the pipeline.The devices were prepared and flushed according to the instructions for use (ifu).
Additional Manufacturer Narrative
Continuation of d10: product id: fg15150-0615-1s, lot: 229782804.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
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 the cause of the event was not determined.
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 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 noted that the vessel tortuosity was minimal 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: 24117530
• Report Number: 2029214-2026-00103
• Device Sequence Number: 21256917
• Product Code: OUT
• UDI-Device Identifier: 00763000449599
• UDI-Public: (01)00763000449599(17)280914(10)D065188
• 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): 03/25/2026

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: PED2-500-35
• Device Catalogue Number: PED2-500-35
• Device Lot Number: D065188
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 01/22/2026; 03/05/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 01/26/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2025
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 70 KG