MAUDE Adverse Event Report: MEDTRONIC, INC. ONYX FRONTIER¿; CORONARY DRUG-ELUTING STENT

Model Number	ONYXNG27522UX
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Delivery of a 7 french guide catheter extension into the proximal right coronary artery segment.Subsequent attempts to deliver a stent were unsuccessful.In retrieving the on deployed stent, it became apparent that the stent stripped off of the balloon likely due to an interaction between the proximal stent edge and the guide extension tip.Attempts to advance balloons through the uninflated stent, which was trapped along the ostium of the right coronary artery, were unsuccessful.They were thereafter able to get femoral artery access and snare the stent but attempts to remove the snared dislodged stent were unsuccessful, and it became apparent that the coronary angioplasty wire was pinned in the right coronary artery.Surgeon attempted to fragment the wire with a cutting balloon, but this proved unsuccessful.Surgeon lastly attempted to cut the wire with a bioptome device but was unable to make contact with the wire floating in the aorta.Fortunately, the patient remained remarkably stable.The right coronary artery remained widely patent, including the distal angioplasty site.At this point, given the inability to free the pinned wire through percutaneous means, cardiothoracic surgery was consulted and kindly brought the patient to the operating room.
Event or Problem Description
Delivery of a 7 french guide catheter extension into the proximal right coronary artery segment.Subsequent attempts to deliver a stent were unsuccessful.In retrieving the on deployed stent, it became apparent that the stent stripped off of the balloon likely due to an interaction between the proximal stent edge and the guide extension tip.Attempts to advance balloons through the uninflated stent, which was trapped along the ostium of the right coronary artery, were unsuccessful.They were thereafter able to get femoral artery access and snare the stent but attempts to remove the snared dislodged stent were unsuccessful, and it became apparent that the coronary angioplasty wire was pinned in the right coronary artery.Surgeon attempted to fragment the wire with a cutting balloon, but this proved unsuccessful.Surgeon lastly attempted to cut the wire with a bioptome device but was unable to make contact with the wire floating in the aorta.Fortunately, the patient remained remarkably stable.The right coronary artery remained widely patent, including the distal angioplasty site.At this point, given the inability to free the pinned wire through percutaneous means, cardiothoracic surgery was consulted and kindly brought the patient to the operating room.

• Brand Name: ONYX FRONTIER¿
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 24625776
• Report Number: 24625776
• Device Sequence Number: 15625533
• Product Code: NIQ
• UDI-Device Identifier: 00763000511401
• UDI-Public: (01)00763000511401
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026
• Report Date (Section F): 03/12/2026

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: ONYXNG27522UX
• Device Catalogue Number: ONYXNG27522UX
• Device Lot Number: 0013087993
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 03/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Date Report Sent to FDA: 03/12/2026