MAUDE Adverse Event Report: Medtronic Ireland ONYX FRONTIER; CORONARY DRUG-ELUTING STENT

Model Number	ONYXNG20008UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the index procedure one prevail drug coated balloon (dcb) was used to treat a lesion with 80% stenosis located in the 1st diagonal artery.Two onyx frontier were also implanted in the 1st diagonal during a second intervention on the same day post the index procedure.Approximately 1 month post the index procedure, the cec adjudicated that the patient suffered from acute lesion thrombosis, arc definite.
Additional Manufacturer Narrative
Additional information: on the same day post the index procedure, the patient suffered from acute lesion thrombosis, arc definite.Post procedure, the patient developed chest pain and st elevation.It was stated that a myocardial infraction also occurred in the target vessel, the lad.Repeat angiography confirmed target lesion thrombosis.It was stated that the thrombosis was related to the prevail dcb.The event was treated with hospitalization and a percutaneous coronary intervention in the target vessel.The patient recovered.The patient was taking dual antiplatelet therapy within 24 hours prior to the event.B2.Outcome attributed to adverse event b3.Date of 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
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 ; +353(091)708096
• MDR Report Key: 50170434
• Report Number: 9612164-2026-03974
• Device Sequence Number: 8281353
• Product Code: NIQ
• UDI-Device Identifier: 00763000511111
• UDI-Public: (01)00763000511111(17)290210(10)0013286422(20)01
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: ONYXNG20008UX
• Device Catalogue Number: ONYXNG20008UX
• Device Lot Number: 0013286422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Supplement Date Received by Manufacturer: 08/31/2026; 09/15/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/11/2026; 09/16/2026
• Date Device Manufactured: 02/11/2026
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 201 LB
• Patient Race: American Indian Or Alaskan Native