MAUDE Adverse Event Report: MEDTRONIC IRELAND ONYX FRONTIER; CORONARY DRUG-ELUTING STENT

Model Number	ONYXNG25018UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Chest Pain (1776); Dyspnea (1816); Dizziness (2194); Heart Block (4444); Restenosis (4576)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the index procedure one prevail drug coated balloon (dcb) was used to treat a lesion with 70% stenosis and in stent restenosis (isr) in an onyx frontier drug eluting stent in the distal right coronary artery (rca).There were multiple medtronic stents placed in the rca originally approximately 12 months previously from the proximal rca to distal rca.The area that was treated for isr during the index procedure was the distal rca.The stent in the distal rca was a 2.5x18mm onyx frontier stent.Approximately 6 months post the index procedure the patient suffered from chest pain/unstable angina.When the patient was seen in cardiology, the patient complained of worsening dyspnea on exertion and sporadic chest pain 1 to 2 times a day.Due to the patients history of in stent restenosis, the patient was scheduled for a cath.However, the patient presented to the er prior to this appointment with 2 days of left sided chest pressure associated with light headedness and shortness of breath with minimal exertion.The patient was hospitalized.An ekg performed found 1st degree av block with no st elevation.Troponins at baseline were 8 and at 2 and 6 hours there was no change from baseline.Due to concern of unstable angina and patient endorsing pressure at rest, patient was admitted and had heart cath the next day and was found to have 70% in stent restenosis in the distal rca 2.5x18mm onyx frontier stent.The patient underwent a pci of the target lesion in the distal rca with a dcb.The patient was also treated with medication.The patient was discharged home.The patient recovered.The patient was not taking dual antiplatelet therapy within 24 hours prior to the event.
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: ONYX FRONTIER
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 25890213
• Report Number: 9612164-2026-03700
• Device Sequence Number: 18589417
• Product Code: NIQ
• UDI-Device Identifier: 00763000511302
• UDI-Public: (01)00763000511302(17)270826(10)0012415338(20)01
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ONYXNG25018UX
• Device Catalogue Number: ONYXNG25018UX
• Device Lot Number: 0012415338
• 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: 07/02/2026
• Initial Report FDA Received Date: 07/21/2026
• Date Device Manufactured: 08/26/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White