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

Model Number	PED2-400-18
Medical Device Problem Codes	Retraction Problem (1536); Unintended Movement (3026); Migration (4003); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an intracranial aneurysm procedure treated with pipeline implantation using the marksman catheter 150cm, catheter resistance was encountered at the distal end.After successful stent deployment, the stent push rod distal end could not be withdrawn into the catheter, resulting in the tip radiopaque marker wire and protective sleeve remaining outside the catheter.The operator was required to remove both the catheter and push rod together, and because the push rod could not be fully withdrawn, its distal part remained outside the catheter and interfered with the stent tip during system removal.This interference caused the stent tip to shift downward by approximately 3 millimeters.The operator had anchored the stent sufficiently high, so after the shift, the stent distal end maintained a 4 millimeter anchoring distance from the aneurysm outflow tract.The access vessel was the right femoral artery with a diameter of 7.6 millimeters, and vessel tortuosity was normal.The catheter and accessory devices were prepared and flushed as indicated in the instructions for use.No patient complications or injuries have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id fa-55150-1030 (229149625).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
B5: additional information added to event summary.D4/h4: device information received.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 reporting that the cause of the event was not determined.Continuous saline flush was administered and maintained as indicated in the ifu.There was no observed damage to the pipeline pushwire or catheter.

• 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: 24037538
• Report Number: 2029214-2026-00053
• Device Sequence Number: 9058253
• Product Code: OUT
• UDI-Device Identifier: 00763000284350
• UDI-Public: (01)00763000284350(17)280622(10)D046737
• 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
• Report Date (Section B): 02/04/2026

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: PED2-400-18
• Device Catalogue Number: PED2-400-18
• Device Lot Number: D046737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2026
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 06/23/2025
• 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: 44 YR
• Patient Sex: Male