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

Model Number	ONYXNG50030UX
Medical Device Problem Codes	Entrapment of Device (1212); Deformation Due to Compressive Stress (2889); Device Dislodged or Dislocated (2923); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
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 and one 6f telescope guide extension catheter, stent dislodgement occurred during delivery to/at the lesion.It was stated that the onyx frontier stent came off inside the telescope when the stent could not be delivered to the lesion.The target lesion was located in the mid right coronary artery (rca) which exhibited severe tortuosity, severe calcification and 80% stenosis.Both devices were inspected prior to use and negative prep was performed, both with no issues noted.The lesion was pre-dilated.The onyx frontier device did not pass through a previously deployed stent.Resistance was encountered when advancing the onyx frontier device and no resistance was encountered when advancing the telescope.Excessive force was used during delivery of both devices.It was noted that the stent felt tight in the telescope during removal of the stent.The dislodged stent was removed within the telescope together.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: the target lesion was located in the proximal right coronary artery (rca).Resistance was noted during withdrawal of the onyx frontier after the attempt to deliver the stent to the proximal lesion.It was believed that the stent may have been damaged when it went back into the telescope gec.Product analysis: the device was returned for evaluation.The dislodged stent was received alongside the delivery system.Kinks were evident to the catheter shaft.Deformation was evident to the dislodged stent.The balloon folds remained intact.Crimp impressions were visible on the exposed balloon surface.Deformation was evident to the distal tip.No other deformation evident to the remainder of the device.Correction: negative prep was performed on the onyx frontier device with no issues noted.The telescope gec was prepped per ifu with no issues noted.It was stated that the stent got stuck in telescope and came off.It was stated that this was a very difficult case.Annex a code a150208.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.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: 24686871
• Report Number: 9612164-2026-01526
• Device Sequence Number: 13193285
• Product Code: NIQ
• UDI-Device Identifier: 00763000511838
• UDI-Public: (01)00763000511838(17)280930(10)0013052839(20)01
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 05/22/2026

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: ONYXNG50030UX
• Device Catalogue Number: ONYXNG50030UX
• Device Lot Number: 0013052839
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 05/08/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/23/2026; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• 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