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

Model Number	ONYXNG30034UX
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/11/2025
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 removal following a failed delivery.The lesion being treated was mildly tortuous, severely calcified in the ostium of the left main (lm) coronary artery.The device was inspected prior to use with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.A 3.0 x 25mm euphora balloon catheter was placed across the lesion and given a single inflation with a maximum inflation pressure of 14 atm.Successful balloon angioplasty was performed.An attempt was made to deliver the 3.0 x 34mm onyx frontier stent but the device could not cross the lesion.Stent dislodgement occurred during removal.The stent came off the balloon partially in the lm and partially in the aorta likely due to lm calcium/stent.Multiple unsuccessful attempts were made to remove the stent with multiple approaches/techniques including multiple snares but were unsuccessful.The stent remained in the patient with the distal end lodged in the left main artery and the proximal portion extending into the aorta.The lesion was left untreated as stent dislodged in the lm with approximately 10mm of the stent in the left main artery and the remainder hanging in the aorta.The decision was made to "cinch" the stent in place with a percutaneous transluminal coronary angioplasty in the lm and then will later cover it up when transcatheter aortic valve replacement (tavr) is performed.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: resistance was noted during withdrawal of the device but excessive force was not used.There was no issues noted with the previously deployed stent as a result of the event.There were no issues noted with the other medtronic devices used during the procedure.Correction: annex a code.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
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: 23543029
• Report Number: 9612164-2025-05614
• Device Sequence Number: 21194436
• Product Code: NIQ
• UDI-Device Identifier: 00763000511524
• UDI-Public: (01)00763000511524(17)280406(10)0012754244(20)01
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 12/19/2025

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: ONYXNG30034UX
• Device Catalogue Number: ONYXNG30034UX
• Device Lot Number: 0012754244
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 12/08/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/02/2025; 12/19/2025
• Date Device Manufactured: 04/07/2025
• 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 Sex: Male