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

Model Number	PED2-375-25
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Retraction Problem (1536); Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is reported at this time based on additional/new information received indicating a reportable event.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
It was reported that a pipeline embolization device was deployed to treat a matricidal, saccular aneurysm in the left carotid artery, which was compressing the carotid and described as very rare.The aneurysm was unruptured, with a neck diameter of 2 mm, and the vessel exhibited moderate tortuosity.Dual antiplatelet treatment had been administered.During the procedure, they deployed the first portion of the stent, waited for a minute to let time for the flow diverter to open properly, load a bit of the system and then completed deployment with not resheathing.The pipeline was said to be perfect.They had to use a transform for balloon angioplasty at the neck as it was said to be super tight anatomy.Two days post-procedure it was observed on imaging that the patient had non-ischemic cerebral enhancing (nice) lesions.There were no patient symptoms, complications, or injury reported as a result of this event.The pipeline landing zone was 3.82mm distal and 3.84mm proximal.The devices were prepared according to the instructions for use (ifu).Additional information received reported the pipeline initially had difficulty opening at the distal end but was ultimately opened and able to be deployed.They tried to resheath the pipeline but it felt like the wings were stuck.When they remove the delivery phenom 27 catheter, it was a bit accordion due to the friction with the wings.The balloon angioplasty was used to dilate the patient's artery which was only 2mm at the aneurysm neck, indicating the dilation with the balloon was due to the patient's anatomy.The pipeline and outcome looked great on post-procedure imaging.
Additional Manufacturer Narrative
B5 updated with additional 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 received reported continuous catheter flush was administered during the procedure as indicated in the instructions for use (ifu).

• 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: 23469080
• Report Number: 2029214-2025-02334
• Device Sequence Number: 12984334
• Product Code: OUT
• UDI-Device Identifier: 00763000284282
• UDI-Public: (01)00763000284282(17)280109(10)D009543
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/04/2025

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: PED2-375-25
• Device Catalogue Number: PED2-375-25
• Device Lot Number: D009543
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/04/2025
• Date Device Manufactured: 01/09/2025
• 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: Unknown