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

Model Number	ONYXNG25022UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure one onyx frontier coronary drug-eluting stent dislodged during delivery to or at the lesion in the circumflex artery.The stent was not deployed.The stent was not able to be removed via a snare or other technique.As an intervention, the stent was crushed against the arterial wall.The device was inspected prior to use with no issues noted.Negative prep was not performed.The lesion being treated was pre-dilated.The device passed through a previously-deployed stent.There was no injury to the patient.The patient was discharged.No further patient complications have been reported as a result of this event.
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.
Additional Manufacturer Narrative
Additional information: it was reported that during a procedure one onyx frontier coronary drug-eluting stent dislodged during delivery to or at the lesion in the proximal left anterior descending artery(lad)/circumflex artery.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 device passed through a previously deployed non-medtronic stent.There were no issues noted with the non-medtronic stent.Patient sex provided.Correction: annex b code.A2 patient age d.6a implanted date.The lesion being treated was in the circumflex artery not the proximal left anterior descending artery.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: STENT, CORONARY, DRUG-ELUTING
• 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: 22991975
• Report Number: 9612164-2025-04422
• Device Sequence Number: 8806471
• Product Code: NIQ
• UDI-Device Identifier: 00763000511319
• UDI-Public: (01)00763000511319(17)280313(10)0012718335(20)01
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 11/06/2025

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: ONYXNG25022UX
• Device Catalogue Number: ONYXNG25022UX
• Device Lot Number: 0012718335
• 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: 08/16/2025
• Supplement Date Received by Manufacturer: 10/06/2025; 10/18/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/16/2025; 11/06/2025
• Date Device Manufactured: 03/14/2025
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 104 KG