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

Model Number	ONYXNG40022UX
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
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
During a procedure an attempt was made to use one onyx frontier coronary drug eluting stent when the device detached, cracked or fractured at the balloon during delivery through the vessel.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.The lesion intended to be treated was a moderately tortuous, non-calcified lesion with 100% stenosis located in the proximal/ostium of the right coronary artery (rca).When the stent was being placed at the lesion it was noted that the balloon was slipping and in order to prevent a full detachment, the stent was deployed in the proximal rca but did not cover the intended lesion in the ostium rca.The device was not kinked and restraightened during use.The device passed through a previously-deployed stent.There was no resistance encountered when advancing the device, and excessive force was not used during delivery.No attempt was made to remove the detached portion.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Correction: another device was used to cover the intended lesion at the ostium of the rca.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: no other device was used to cover the intended lesion at the ostium of the right coronary artery (rca).The detached portion was secured within the vessel.Full balloon detachment did not occur, as it was prevented when the stent was placed.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: 25200175
• Report Number: 9612164-2026-02562
• Device Sequence Number: 21055097
• Product Code: NIQ
• UDI-Device Identifier: 00763000511678
• UDI-Public: (01)00763000511678(17)290124(10)0013256690(20)01
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/09/2026

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: ONYXNG40022UX
• Device Catalogue Number: ONYXNG40022UX
• Device Lot Number: 0013256690
• 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: 04/28/2026
• Supplement Date Received by Manufacturer: 05/19/2026; 05/19/2026; 06/30/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 05/25/2026; 06/17/2026; 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2026
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 84 KG