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

Model Number	ONYXNG20015UX
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
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.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 euphora rx coronary balloon and one 2.0 x 15 mm onyx drug eluting stent were used.The target lesion was located in the ostium of the circumflex (cx) and obtuse marginal (om) which exhibited no tortuosity and no calcification.30-40% lesion stenosis was present in the ostial cx and 80% lesion stenosis was present in the om.No issues were noted on the devices prior to use.Negative prep was performed with no issues noted.The lesion was pre-dilated with the euphora balloon with no issues.Resistance was not encountered while advancing the device and excessive force was not used during delivery.The balloon burst when inflated to nominal pressure.After removal of the balloon, imaging was performed to assess the vessel and contrast dye status, which initially made the vessel appear to be dissected.The physician took another picture after balloon removal, and the contrast dye was gone.The balloon was evaluated outside the body and demonstrated a ruptured balloon.The onyx device failed to cross the lesion.The patient was asymptomatic and there appeared to be no extravasation.Bedside echo revealed no pericardial effusion.Given the patient was asymptomatic and hemodynamically stable, it was determined not to proceed with further intervention.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: negative prep was performed on the euphora with no issues noted.The euphora balloon was not moved or repositioned while inflated.The balloon ruptured on the first inflation.It was stated that the euphora balloon caused the dissection.A 2.0 x 15 mm onyx frontier stent was attempted to be placed in the vessel.The onyx frontier stent was inspected prior to use with no issues noted.Resistance was noted while advancing the stent but excessive force was not used.The dissection occurred prior to the use of the stent.The stent was initially intended to treat the lesion, however after noticing the dissection, its purpose was to treat the dissection and the lesion.Difficulty was encountered crossing the onyx frontier stent and it could not be advanced.A 2.0 x 12mm stent was chosen instead which was successful.The patient was stable and unharmed.Initial reporter name and phone number.Lot number provided.Correction: the circumflex provided collaterals to right coronary artery (rca).There appeared to be a contained dissection.Section b1: adverse event 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: annex d code.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: 24679986
• Report Number: 9612164-2026-01497
• Device Sequence Number: 13262883
• Product Code: NIQ
• UDI-Device Identifier: 00763000511135
• UDI-Public: (01)00763000511135(17)280718(10)0012929076(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
• 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): 05/07/2026

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: ONYXNG20015UX
• Device Catalogue Number: ONYXNG20015UX
• Device Lot Number: 0012929076
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 04/13/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/09/2026; 05/07/2026
• Date Device Manufactured: 07/19/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 121 KG