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

Model Number	PED2-500-20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
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 the surgeon used a dense mesh stent (ped2-500-20) to treat the aneurysm.The stent was delivered after the stent catheter reached beyond m1 and deployed in the straight section.The stent tip failed to open normally.The surgeon tried many times and deployed it to a sufficient distance but still failed to open.The surgeon then withdrew the stent and the stent microcatheter as a whole from the body.The stent was pushed out of the body and opened normally.At this time, the stent microcatheter could not be delivered normally.After the microcatheter was replaced and delivered to the right place, the stent was delivered again to complete the operation.The catheter was kinked.No patient symptoms or further complications were reported as a result of this event.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.The patient was undergoing surgery for treatment of a saccular, unruptured left ophthalmic artery aneurysm.It was noted the patient's vessel tortuosity was moderate.The access vessel was the right femoral artery with a diameter of 8.1 mm.
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 was received stating that the stent catheter phenom27 was kinked and could not be delivered.The cause of the kink, delivery issue, and failure to open was not determined.The pipeline had not been placed in a vessel bend when it failed to open.Additional information was received stating that the dense mesh stent had been successfully implanted.
Additional Manufacturer Narrative
H6: update - pli 20 was never returned, previous coding was incorrect.Device remains in the patient.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: 22169984
• Report Number: 2029214-2025-01336
• Device Sequence Number: 21145934
• Product Code: OUT
• UDI-Device Identifier: 00763000284725
• UDI-Public: (01)00763000284725(17)270809(10)B771747
• 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): 08/06/2025

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: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: B771747
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 06/11/2025; 08/06/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/03/2025; 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2024
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 83 KG