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

Model Number	ONYXNG45022UX
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
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 one onyx frontier coronary drug eluting stent deformed in vivo during positioning/advancement.The lesion being treated was non-tortuous, moderately calcified in the ostium of the right coronary artery (rca).Negative prep was performed prior to use with no issues.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the stent. intravascular ultrasound (ivus) was conducted, and it was noted that the degree of calcium was underestimated.The stent did not cross the lesion on the first attempt, so it was removed to prevent further dilation.Upon inspection prior to reinsertion, the stent was noticed to be bunched up on balloon.It was stated that the issue was attributed to the calcium present,not the stent itself.A non-medtronic guide extension catheter and a new stent were used to complete the procedure.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: the device returned for evaluation.The stent was positioned on the balloon between the marker bands in accordance with the positioning specification.However, due to deformation, the stent did not meet the visual acceptance criteria.Deformation was observed on the mid wraps, with struts raised.No deformation was evident on the distal tip.The device also returned with a detachment on the hypotube.The detachment site on the hypotube material was oval and jagged.Kinks were evident on the hypotube proximal distal to the detachment site.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.
Additional Manufacturer Narrative
Additional information: the device was inspected prior to use with no issues.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: 23424865
• Report Number: 9612164-2025-05331
• Device Sequence Number: 20896447
• Product Code: NIQ
• UDI-Device Identifier: 00763000511753
• UDI-Public: (01)00763000511753(17)280311(10)0012712922(20)01
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 12/04/2025

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: ONYXNG45022UX
• Device Catalogue Number: ONYXNG45022UX
• Device Lot Number: 0012712922
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/03/2025; 11/26/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/10/2025; 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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 Sex: Male