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

Model Number	ONYXNG20015UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2026
Type of Reportable Event	Malfunction
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
During a percutaneous coronary intervention (pci) procedure an attempt was made to use one onyx frontier coronary drug eluting stent when stent dislodgement occurred during removal following failed delivery.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The lesion being treated was a mildly tortuous, moderately calcified lesion with 90% stenosis located in the mid-proximal circumflex (cx) artery and obtuse marginal (om).A 2.5 x 12 mm compliant balloon was used, followed by a non-medtronic cutting balloon in the mid lcx artery.A non-medtronic 3.0 x 32 mm des was placed and post-dilated with a 3.5 mm nc balloon.The om1 showed a moderate lesion and was treated with angioplasty.The patient complained of chest pain 2 hours later and was taken back for a relook, and was found to have stent thrombosis.Intravascular ultrasound (ivus) showed calcium and thrombus.Coronary thrombectomy was performed on the patient followed by coronary 3.0 shockwave intravascular lithotripsy (ivl).An attempt was made to place a non-medtronic 2.25 mm des in om1.The stent was removed undeployed.A 2.0 mm nc balloon was used in the om1.Another attempt was made to deploy the non-medtronic 2.25 mm des, which was unsuccessful.Then the 2.0 x 15 mm onyx frontier des was attempted to be deployed.The onyx stent was unable to cross and the stent was removed undeployed.Upon removal, the stent was dislodged in the 7f catheter.The stent was recaptured and removed from the patient using a 7f catheter and guidewire.No guide extension catheter used.The device did pass through a previously-deployed stent.There was no resistance encountered when advancing the device, and excessive force was not used during delivery.No patient complications were reported as a result of the event.

• 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: 25483521
• Report Number: 9612164-2026-03039
• Device Sequence Number: 16064519
• Product Code: NIQ
• UDI-Device Identifier: 00763000511135
• UDI-Public: (01)00763000511135(17)280714(10)0012922085(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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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: ONYXNG20015UX
• Device Catalogue Number: ONYXNG20015UX
• Device Lot Number: 0012922085
• 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: 05/18/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 07/13/2026
• Date Device Manufactured: 07/15/2025
• 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
• Patient Age: 58 YR
• Patient Sex: Female