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

Model Number	PED2-350-35
Medical Device Problem Codes	Retraction Problem (1536); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that when delivering the pipeline flex with shield technology stent within the patient, it encountered resistance in the middle of the phenom 27 microcatheter and could neither be retrieved nor deployed.To ensure patient safety, the stent together with the microcatheter were removed from the patient.Outside the patient's body, the stent was separated from the microcatheter, and pleating deformation of the stent was observed, which caused it to be stuck inside the microcatheter and unable to be pushed out.It was also reported that the stent was not stuck.The stent was replaced with another stent of the same model but 5 mm shorter for implantation using the same microcatheter, without changing the microcatheter.No patient symptoms or complications were associated with this event.The patient was undergoing dense mesh flow diversion surgery for treatment of an unruptured, saccular, c7 segment aneurysm with a max diameter of 12 mm and a 11 mm neck diameter.The landing zone arterial diameter was 3.2 mm distally and 3.7 mm proximally.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet treatment (dapt) was administered.The platelet reactivity unit (pru) level was noted as within the acceptable range.The hospital required all flow-diverting stent procedures to continue dual antiplatelet therapy for 7 days with testing.The angiographic result post procedure reported large aneurysm.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The pipeline was used for an approved indication (on-label).The catheter was flushed continuously with heparanized saline.There was no damage to the catheter or pushwire.Ancillary devices included 8f guide catheter, navien intracranial support catheter, phenom27 microcatheter, synchro14 guidewire.
Additional Manufacturer Narrative
Continuation of d10: phenom 27 microcatheter: product id unk-nv-fg15 (unknown);  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 received that it was clarified that the stent was stuck in the middle of the catheter.The stent had a "pleating deformation" on the mid-segment.There were no causes or contributing factors identified for the resistance or the stent deformation.It was confirmed the stent deformation was not caused by the 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: 24649920
• Report Number: 2029214-2026-00487
• Device Sequence Number: 10168703
• Product Code: OUT
• UDI-Device Identifier: 00763000449056
• UDI-Public: (01)00763000449056(17)280818(10)D058507
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2026

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: PED2-350-35
• Device Catalogue Number: PED2-350-35
• Device Lot Number: D058507
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 05/01/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/21/2026; 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2025
• 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: 72 YR
• Patient Sex: Male