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

Model Number	ONYXNG40008UX
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	07/06/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that during a procedure involving one onyx frontier coronary drug-eluting stent, the stent was damaged by another device.The lesion being treated was moderately tortuous and moderately calcified located in the ostium of the left main (lm) coronary artery.The stent was placed and successfully deployed in the lm.Another stent was then placed in the left anterior descending a rtery(lad).Another stent was placed in the ramus using a non-medtronic guidewire.When it was attempted to retrieve the guidewire, it locked up with the deployed stent in the lm.The guidewire was pulled and the stent was expanded and removed from the patient stuck to the guidewire.The stent did not pass through a previously deployed stent.No resistance was encountered when advancing the device and no excessive force was used during delivery.The stent was inspected prior to use and negative prep was performed with no issues.The patient died the following day.The physician assessed that the death was related to gastrointestinal (gi) bleed and was not due to the issues encountered with the stent.
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: another 4.00x08mm onyx frontier stent was then placed in the left anterior descending artery(lad) with no issues noted.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 stent was returned for evaluation.The returned stent was found to be deformed, with stretched stent wraps.Additionally, a section of the guidewire, including its stretched coils, was wrapped around the deformed stent.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: 22662798
• Report Number: 9612164-2025-03707
• Device Sequence Number: 3677724
• Product Code: NIQ
• UDI-Device Identifier: 00763000511630
• UDI-Public: (01)00763000511630(17)270602(10)0012297946(20)01
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 09/16/2025

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: ONYXNG40008UX
• Device Catalogue Number: ONYXNG40008UX
• Device Lot Number: 0012297946
• 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: 07/06/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 09/10/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/29/2025; 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown
• Patient Weight: 77 KG