MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO PGLA HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	PV-20-50-HELIX
Medical Device Problem Codes	Compatibility Problem (2960); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2026
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 device passed through a previously deployed stent.The device was not used on patient.There was accessory device incompatibility.A 0.18" microcatheter was used because a rebar 18 catheter was not available due to a back order.There were no patient symptoms or complications associated with this event.No medical or surgical intervention required.The issue was resolved on (b)(6) 2026.The patient was supposed to undergo thoracoabdominal aneurysm embolization surgery of the polar left renal artery.It had a diameter of 8 mm.It was noted the patient's vessel tortuosity was normal.There were no abnormalities reported in relation to anatomy.Ancillary devices include a vertebral catheter 5fr diagnostic catheter and a moma 150 boston scientific catheter.
Additional Manufacturer Narrative
Sections with additional information as of 21-may-2026: d9: device returned to manufacturer h3: device evaluated by manufacturer.H6: updated fda's type of investigation, investigation findings, and investigation conclusions h10: meter was returned for evaluation: reported defect not reproduced on returned meter most likely underlying root cause: (b)(6): user had an inaccurate reference: competitor¿s meter: the end user is comparing results obtained from trividia¿s bgm system to the results from a competitor¿s bgm system.
Event or Problem Description
Additional information was received reporting that the causes or contributing factors for the event was identified as, "during advan cement through the microcatheter, the device did not advance and became trapped within the internal lumen of the microcatheter.Due to the urgency of the situation and the unavailability of another microcatheter, the coil was advanced through the hypotube; however, the coil did not adequately conform, so the physician decided to remove it from the patient." "the event occurred during the endovascular surgical procedure." the patients vessel tortuosity was normal.The left polar renal artery was not embolized due to the unavailability of a microcatheter.Continuous flushing was performed to ensure patency and prior to purging.

• Brand Name: CONCERTO PGLA HLX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 24929583
• Report Number: 2029214-2026-00703
• Device Sequence Number: 5179874
• Product Code: KRD
• UDI-Device Identifier: 00847536045064
• UDI-Public: (01)00847536045064(17)281113(10)D084256
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K090046
• 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): 06/24/2026

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: PV-20-50-HELIX
• Device Catalogue Number: PV-20-50-HELIX
• Device Lot Number: D084256
• 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: 04/18/2026
• Supplement Date Received by Manufacturer: 04/22/2026; 05/27/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/21/2026; 06/24/2026
• Date Device Manufactured: 12/12/2025
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 74 KG