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

Model Number	ONYXNG27522UX
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
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
It was reported that during a procedure involving one onyx frontier coronary drug eluting stent, stent deformation occurred in vivo during positioning/advancement.It was reported that the stent would not cross the severely calcified lesion and the front end of the stent strut was pushed up.An attempt was made to use a 7f telescope guide extension catheter but the stent would not go through.The procedure was completed with a different stent, which successfully crossed the lesion.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: the stent would not advance through the telescope gec.There were no issues noted with the onyx frontier prior to use.The lesion was predilated.The device did not pass through a previously deployed stent.There were no issues noted with the telescope device.The deformed stent was pulled out.Resistance was not noted while removing the device from the lesion.The procedure was completed with a different medtronic stent, which successfully crossed the lesion with no issues noted.Product analysis: kinks were evident to the catheter shaft.Deformation was evident to the distal stent struts with struts raised and pulled distally.Deformation was evident to the distal tip.No other damage was observed on the remainder of the device.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: 23801219
• Report Number: 9612164-2025-06189
• Device Sequence Number: 7686505
• Product Code: NIQ
• UDI-Device Identifier: 00763000511401
• UDI-Public: (01)00763000511401(17)280608(10)0012859403(20)01
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 01/20/2026

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: ONYXNG27522UX
• Device Catalogue Number: ONYXNG27522UX
• Device Lot Number: 0012859403
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown