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

Model Number	ONYXNG25026UX
Medical Device Problem Codes	Premature Activation (1484); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
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
It was reported that during a procedure involving one onyx frontier coronary drug eluting stent, stent deformation occurred in vivo.The device was attempted to be used in the patient, then removed and the device looked okay.The device was then inserted for the second time and when the device was removed again, the stent felt expanded more on the distal end rather than the proximal end.It was not possible to load the stent into the copilot easily.It felt like the stent was not crimped entirely on the balloon and the stent was described to be "winged".The device was not hooked up to a indeflator.The lesion intended to be treated was the distal right coronary artery (rca).There was no damage noted to the packaging, the packaging was intact and undamaged prior to opening.The device protective sheath was removed per ifu.There was no gap noticeable between the retractable sheath and the tip when device was removed from the packaging.There were no issues noted when removing the device from the hoop/tray.The stent was inspected after removal of the protective sheath and the struts looked smooth, no device issues were noted.The red clip was in the correct position when the exposed stent was noted.Negative prep was not performed.The stent was loaded onto a 0.014 guidewire and no force was applied.The device was replaced with the same size stent and the procedure was successfully completed. no patient complications were reported as a result.

• 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: 25200982
• Report Number: 9612164-2026-02563
• Device Sequence Number: 10096427
• Product Code: NIQ
• UDI-Device Identifier: 00763000511326
• UDI-Public: (01)00763000511326(17)281208(10)0013180684(20)01
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• 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): 06/17/2026

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: ONYXNG25026UX
• Device Catalogue Number: ONYXNG25026UX
• Device Lot Number: 0013180684
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 06/17/2026
• Date Device Manufactured: 12/09/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown