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

Model Number	PED2-475-25
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
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 pipeline flex stent middle segment failed to open.In addition, during removal, the stent was stuck within the phenom 27 stent catheter and could not be taken out.The patient was undergoing surgery for treatment of an unruptured saccular aneurysm with a max diameter of 4.71 mm and a 6.1 mm neck diameter.It was noted the patient¿s vessel tortuosity was severe.The access vessel was the femoral artery.It was reported that the lesion was an aneurysm of the ophthalmic artery segment of the internal carotid artery, and ped2-475-25 was selected for implantation.After adequate hydration, the ped2-475-25 was delivered to the stent catheter.During deployment, the flow-diverting stent failed to open in the mid-segment, and multiple attempts by the operator were unsuccessful.Before the stent was deployed prior to reaching the marker point, repeated pushing and pulling still failed to open the stent normally.Considering that multiple attempts could easily cause intimal injury to the patient¿s vessel, the operator had to remove the stent.However, during removal, the stent stuck within the stent catheter and could not be taken out.Therefore, both the flow-diverting stent and the stent catheter were both reported and returned.The pipeline was not used for an indication that is not approved (off-label).The pipeline and any accessory devices were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.No patient symptoms were reported.The angiographic result post procedure were good.Ancillary devices include a phenom plus guide catheter (fg19120-1030-1s/231270024) and phenom 27 catheter (fg15150-0615-1s/230455815).
Additional Manufacturer Narrative
H3: analysis results were not available at the time of this report.A follow-up will be sent once 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 received reported that the pipeline was placed in a vessel bend when it failed to open.

• 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: 24523740
• Report Number: 2029214-2026-00375
• Device Sequence Number: 15883972
• Product Code: OUT
• UDI-Device Identifier: 00763000449483
• UDI-Public: (01)00763000449483(17)280826(10)D060986
• 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): 05/06/2026

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: PED2-475-25
• Device Catalogue Number: PED2-475-25
• Device Lot Number: D060986
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 04/16/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/02/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2025
• 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: 65 YR
• Patient Sex: Female