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

Model Number	ONYXNG30034UX
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
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 during positioning/advancement.The stent strut got caught on the guide catheter when trying to deliver the stent to the lesion.The stent was removed successfully from the guide catheter.The lesion being treated was non-tortuous and located in the proximal left anterior descending (lad) artery.The device was inspected prior to use with no issues.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.There was resistance encountered when advancing the device but excessive force was not used during delivery.The device was replaced with another medtronic 3.0x34mm stent and the procedure was completed successfully.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Additional information: a 6f launcher guide catheter was used during the procedure.Per the physician, the stent deformation was caused by the stent getting caught on the guide catheter, but was not certain on what caused the stent to catch as prior to loading the stent it was inspected and appeared intact without issues.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 proximal stent wraps with struts raised.No deformation evident on 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: 25182085
• Report Number: 9612164-2026-02531
• Device Sequence Number: 10385512
• Product Code: NIQ
• UDI-Device Identifier: 00763000511524
• UDI-Public: (01)00763000511524(17)280919(10)0013030469(20)01
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/02/2026

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: ONYXNG30034UX
• Device Catalogue Number: ONYXNG30034UX
• Device Lot Number: 0013030469
• 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: 04/24/2026
• Supplement Date Received by Manufacturer: 05/22/2026; 06/17/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/10/2026; 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2025
• 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: Female