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

Model Number	PED2-450-18
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
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 stent's tip end failed to open.The patient was undergoing surgery for treatment of a saccular, unruptured ophthalmic artery segment aneurysm with a max diameter of 6.7 mm and a 4.5 mm neck diameter.The landing zone was 4.6 mm distally and 4.4 mm proximally.It was noted the patient's vessel tortuosity was moderate.The angiographic result post procedure was "patent vessels." it was reported that during treatment of a ra'b ophthalmic segment aneurysm, the tip end of the stent failed to open.Multiple attempts were made to recapture and redeploy it, but the stent still could not be opened.After switching to another stent, the procedure proceeded smoothly.The pipeline was not used for an indication that is not approved (off-label).The pipeline and accessory devices were prepared as indicated in the instructions for use (ifu).There were no patient symptoms or complications associated with this event.Ancillary devices include a navien guide catheter.
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.
Event or Problem Description
Additional information was received.The causes and contributing factors for the failure to open were unknown.The pipeline did not open in the distal section.The pipeline was placed in the straight section when it failed to open.The pipeline was recaptured and redeployed in an attempt to open the pipeline.The angiographic result post procedure shows the contrast agent was clearly visualized on the angiography.The "ra'b" was a typographical error.The information has been confirmed/provided by the physician.
Additional Manufacturer Narrative
H2: the correct fdm/fdr/fdc codes were updated and applied.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: 24639423
• Report Number: 2029214-2026-00479
• Device Sequence Number: 9797558
• Product Code: OUT
• UDI-Device Identifier: 00763000449377
• UDI-Public: (01)00763000449377(17)280919(10)D066692
• 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,Followup
• Report Date (Section B): 05/27/2026

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: PED2-450-18
• Device Catalogue Number: PED2-450-18
• Device Lot Number: D066692
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 03/22/2026; 04/08/2026; 04/30/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/17/2026; 04/21/2026; 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2025
• 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 Sex: Male