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

Model Number	PED2-375-16
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	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s ((b)(6)); product type: ; implant date n/a; explant date n/a.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 information regarding a phenom 27 microcatheter that had resistance and resheathing a pipeline flow diversion stent and became damaged.The patient was undergoing a procedure via right femoral access for flow diversion treatment of a brain aneurysm.Vessel tortuosity was moderate.It was reported that the devices were prepared and catheter flushed per the instructions for use (ifu).During deployment, the pipeline needed to be repositioned.However, there was significant resistance when trying to resheath the pipeline in the phenom microcatheter and the catheter became damaged/kinked at the distal end and stretched in the middle.It felt rough and curved.It was noted that force was not applied.The catheter tip was not stuck or entrapped and was not stuck in the guide catheter.There was no patient vessel vasospasm.The catheter was replaced to continue the procedure.There was no harm or injury to the patient.
Event or Problem Description
Additional information was received.The aneurysm was a 6 mm irregular, broad-neck right posterior communicating artery aneurysm (distal), with no classification provided.The pipeline was trapped in the phenom catheter, and the operator could not specify where the resistance occurred.No damage to the pipeline or pushwire was recalled.The pipeline could not be rescued and was removed along with the catheter.The procedure was completed using another system with a pipeline from the same lot, which was successfully implanted.
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.

• 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: 22010813
• Report Number: 2029214-2025-01173
• Device Sequence Number: 5343117
• Product Code: OUT
• UDI-Device Identifier: 00763000284251
• UDI-Public: (01)00763000284251(17)261025(10)B646026
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/15/2025

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: PED2-375-16
• Device Catalogue Number: PED2-375-16
• Device Lot Number: B646026
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 09/15/2025
• Date Device Manufactured: 10/26/2023
• 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 Age: 74 YR
• Patient Sex: Female