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

Model Number	PED2-375-14
Medical Device Problem Codes	Retraction Problem (1536); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a pipeline that failed to be resheathed with the phenom 27 microcatheter due to the ptfe sleeves and the catheter was damaged.The patient was undergoing an aneurysm embolization procedure to treat a posterior communicating artery (pcom) unruptured saccular aneurysm.The aneurysm max diameter was 4mm and the neck diameter was also 4mm.Dual antiplatelet treatment (dapt) was administered.Vessel tortuosity was severe.It was reported that the devices were prepared per the instructions for use (ifu).The catheter was flushed continuously with heparinized saline.During deployment, the pipeline could not be resheathed.It seems the ptfe sleeves were jammed at the distal tip of the microcatheter.The phenom 27 microcatheter sustained accordion damage due to the pipeline ptfe sleeves being jammed into the catheter distal tip.The pipeline pushwire was not damaged.The system was removed and another pipeline was used to complete the procedure successfully.There was no harm or injury to the patient associated with this event.Post-procedure angiographic results "looked good.".
Additional Manufacturer Narrative
Continuation of d10: product id unk-nv-fg15 (unknown); implant date n/a; explant date n/a e1.It was indicated that physician/initial reported information would not be provided due to privacy regulations.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: 23571216
• Report Number: 2029214-2025-02415
• Device Sequence Number: 15982643
• Product Code: OUT
• UDI-Device Identifier: 00763000284244
• UDI-Public: (01)00763000284244(17)280507(10)D037974
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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
• Report Date (Section B): 11/17/2025

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: PED2-375-14
• Device Catalogue Number: PED2-375-14
• Device Lot Number: D037974
• 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: 10/23/2025
• Initial Report FDA Received Date: 11/17/2025
• Date Device Manufactured: 05/08/2025
• 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 Sex: Female