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

Model Number	ONYXNG25018UX
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
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.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, the device detached, cracked or fractured during removal of the device.The detached portion of device remains in the patient.The lesion being treated was in the proximal circumflex (cx) artery. resistance was not encountered when advancing the device.Excessive force was not used during delivery.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: on the angiographic images it was noted that the stent was possibly broke into 2 pieces.No attempts were made to remove the detached portion and was not removed from the patient.Another stent was placed to secure with no issues noted with deploying the stent covering the initial stent.The lesion being treated was mildly tortuous, mildly to moderately calcified in the proximal circumflex (cx) artery.The device was inspected before use with no issues noted.Negative prep was only performed when the stent was positioned at the lesion, then negative pull on inflation device was performed with no issues noted.Resistance was not encountered when advancing the device.The lesion was not pre-dilated, direct stenting was carried out.Resistance was noted during withdrawal of the device.It was noted that the guidewires used on the lad and circumflex appeared possibly tangled.Excessive force was not used.The device was not kinked and re-straightened during use.No further patient complications have been reported as a result of this event.Lot number, patient weight and initial reporter first name added.B.Adverse event or product, outcome attributed to adverse event, h1.Type of reportable event and imf codes updated.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 stent placed to cover and secure the detached device was a medtronic onyx stent.The guidewires used during the procedure were non-medtronic devices.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: 24066614
• Report Number: 9612164-2026-00224
• Device Sequence Number: 13044072
• Product Code: NIQ
• UDI-Device Identifier: 00763000511302
• UDI-Public: (01)00763000511302(17)270404(10)0012212843(20)01
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 03/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ONYXNG25018UX
• Device Catalogue Number: ONYXNG25018UX
• Device Lot Number: 0012212843
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/21/2026; 02/11/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/11/2026; 03/09/2026
• Date Device Manufactured: 04/04/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 62 KG