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

Model Number	PED3-027-450-25
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure involving the pipeline embolization device for an unruptured saccular aneurysm located in the left internal carotid artery, a pipeline did not open at the proximal end.The aneurysm had a maximum diameter of 3.9 millimeters and a neck diameter of 3.2 millimeters, with a landing zone artery size of 3.6 millimeters distal and 4.6 millimeters proximal.The vessel tortuosity was moderate.The device was resheathed around four times but did not respond as expected, with the failure to open occurring after more than 50% of the device was deployed.The pipeline was not positioned in a bend, and no other steps were taken to open the device.The pipeline was removed from the patient and resheathed and removed with the microcatheter.The pipeline was replaced with another of the same measurements, which also did not open proximally.A pipeline of a different size worked fine. dual antiplatelet treatment was administered, and the angiographic result post-procedure was successful.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id ped3-027-450-25 (b730899); 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Product analysis: damage location details: no bent or kink was found with pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No defects were found with the tip coil, distal marker, re-sheathing marker, arms or with the proximal bumper.The distal and proximal ends of pipeline vantage shield braid were found to be fully opened and damaged.No other anomalies were observed.Testing/analysis: the pipeline vantage shield device was pushed out from introducer sheath without any issue.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 VANTAGE WITH 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: 21092821
• Report Number: 2029214-2025-00062
• Device Sequence Number: 9105857
• Product Code: OUT
• UDI-Device Identifier: 00847536036833
• UDI-Public: 00847536036833
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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: PED3-027-450-25
• Device Catalogue Number: PED3-027-450-25
• Device Lot Number: B730899
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 60 YR
• Patient Sex: Male