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

Model Number	ONYXNG35015UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure involving two onyx frontier coronary drug eluting stents, it was reported that one onyx frontier stent dislodged within a 6f launcher guide catheter and one onyx frontier stent deformed right out of the hoop.The onyx frontier stent that dislodged in the guide catheter was inspected prior to use with no issues noted.There was no difficulties noted when removing the protective sheath/stylette.The stent was inspected post removal of the protective sheath with no issues noted.The lesion was pre-dilated.The lesion being treated was non calcified.The 6f launcher guide catheter was in the patient's vessel when the stent became dislodged within the guide.The dislodged stent was removed.There were no issues reported with the guide catheter and the guide catheter was not believed to have caused or contributed to the stent dislodgement.The inflation device remained on neutral pressure during delivery of the device.No resistance was noted when advancing the device to the lesion.The onyx frontier stent that deformed right out of the hoop was inspected after removal of the protective sheath and strut deformation was observed.There was no damage noted to the packaging.There were no difficulties noted when removing the device from the hoop.There was no resistance noted when removing the protective sheath.The protective sheath was not gripped on the most distal end of the sheath during removal from over the stent/balloon.The stent was handled directly post removal of the protective sheath.The deformed onyx frontier stent was not used in the patient.Negative prep was not performed on both devices.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Product analysis summary: the device was returned to medtronic for evaluation.The stent was not present on the balloon and did not return for analysis.The balloon folds remained intact with crimp impressions were visible on the exposed balloon surface.No other damage evident to the remainder of the device.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: 25238839
• Report Number: 9612164-2026-02630
• Device Sequence Number: 18513992
• Product Code: NIQ
• UDI-Device Identifier: 00763000511562
• UDI-Public: (01)00763000511562(17)281214(10)0013192802(20)01
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 07/14/2026

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: ONYXNG35015UX
• Device Catalogue Number: ONYXNG35015UX
• Device Lot Number: 0013192802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown