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

Model Number	ONYXNG22538UX
Medical Device Problem Codes	Entrapment of Device (1212); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/14/2025
Type of Reportable Event	Serious Injury
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 during a procedure one onyx frontier coronary drug eluting stent failed to cross the lesion.The lesion being treated was non-tortuous, mildly calcified and located in the ostium left main (lm) coronary artery.The device was inspected prior to use with no issues noted.Negative prep was performed with no issues noted. the lesion was pre-dilated with a euphora balloon, but the vessel/lesion was not prepped for calcium prior to stenting. the device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during device delivery. it was detailed that the stent became stuck on the stepdown of the non-medtronic guide extension catheter (gec) and guide.The non-medtronic guidewire was trapped in the stent strut when the stent was deployed.There was then difficulty removing the non-medtronic gec, guidewire, and guide.After removal of the non-medtronic gec and guidewire, the stent was observed to be hanging in the aorta.The stent was then crushed into the lm using a non-medtronic balloon.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: the size of the non-medtronic guidewire trapped was 0.14x190cm.It was later detailed that the stent was stuck in the non-medtronic guide extension catheter (gec).The stent was pushed through with a non-medtronic 1.0x10mm balloon but it could not get the stent down the vessel and the stent could not be pulled back into the gec.It took a while to get the stent to deploy, as the stent was trying to get into a vessel but couldn't, and ultimately ended up in the left main (lm) artery.It was attempted to take the stent out but it couldn't.There was no resistance noted during withdrawal of the stent delivery system.B7 - relevant patient medical history added.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 stent was not able to cross the lesion to deploy and was also not able to be pulled back through the non medtronic gec.The stent had to be deployed where it was.The stent was observed to be hanging in the aorta and needed to be pushed into the lm.It was difficult to position and advance the stent into the correct vessel.There was no difficulty removing the launcher guide catheter from the guidewire or the patient.The non medtronic wire did not get stuck in the stent.Correction: the guide catheter used was a 6f launcher guide catheter.There were no issues noted with the euphora balloon used for pre-dilation.The non-medtronic guidewire was a 0.014x190cm device.Annex a code a150207 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: - annex d updated.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: 22343519
• Report Number: 9612164-2025-03185
• Device Sequence Number: 15596667
• Product Code: NIQ
• UDI-Device Identifier: 00763000511265
• UDI-Public: (01)00763000511265(17)270324(10)0012199342(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
• 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,Followup
• Report Date (Section B): 09/08/2025

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: ONYXNG22538UX
• Device Catalogue Number: ONYXNG22538UX
• Device Lot Number: 0012199342
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 07/29/2025; 09/08/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/29/2025; 08/25/2025; 09/08/2025
• Date Device Manufactured: 03/24/2024
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 92 KG