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

Model Number	ONYXNG25018UX
Medical Device Problem Codes	Inflation Problem (1310); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582); Coronary obstruction/occlusion (4871)
Date of Event	07/23/2025
Type of Reportable Event	Death
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 inflation difficulties occurred during the deployment of one onyx frontier coronary drug-eluting stent.Upon at tempted inflation, only the distal edges of the balloon inflated in the ostial left anterior descending (lad) artery, and the stent failed to expand.The device had been inspected prior to use, with no issues observed.The lesion had been pre-dilated before the attempted deployment, and no resistance was noted while advancing the device to the lesion.The same inflation device was used for both the pre-dilation balloon and the stent balloon.Nominal pressure of 12 atm was applied when the inflation difficulties were identified.The patient experienced cardiac arrest, was intubated, defibrillated, and transferred to the intensive care unit (icu).The physician believes the inflation difficulties caused occlusion of flow in the lad.The patient subsequently expired in the icu.
Additional Manufacturer Narrative
Additional information: the cause of death is unknown.The patient subsequently expired in the icu approximately 2 days post procedure.The cause of death is unknown.Patient race and ethnicity provided.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: -device returned correction: - model - catalogue - lot number - expiration date - unique identifier (udi) - device mfg date 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
Product analysis: the device returned for evaluation.Kinks were evident along the hypotube and at the guidewire entry port.The device returned with balloon folds expanded.No evidence of necking on the proximal balloon bond / distal inflation lumen.The stent was flattened.Contrast was evident in the inflation lumen.The proximal balloon markerband was flattened.It was not possible to perform negative prep due to the condition of the proximal markerband.An attempt was made to inflate the balloon to 8 atms but the balloon could not be inflated due to contrast present in the inflation lumen and the flattened markerband blocking the inflation lumen.No other deformation evident to the remainder of the device.Correction: annex e code e2403 removed.Annex d d12 code added.Annex f codes.Section d.Suspect medical device information in previous report was new information not a correction.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: 22798134
• Report Number: 9612164-2025-03972
• Device Sequence Number: 8264629
• Product Code: NIQ
• UDI-Device Identifier: 00763000511302
• UDI-Public: (01)00763000511302(17)271128(10)0012564719(20)01
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/08/2025

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: ONYXNG25018UX
• Device Catalogue Number: ONYXNG25018UX
• Device Lot Number: 0012564719
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 08/18/2025; 10/06/2025; 12/01/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/15/2025; 10/23/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Death; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White