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

Model Number	ONYXNG27515UX
Medical Device Problem Codes	Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
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
It was reported that during a procedure involving one onyx frontier coronary drug-eluting stent, the device was unable to cross the lesion.The device was noted to be deformed when it was removed from the patient.The lesion being treated was moderately calcified in the proximal circumflex (cx) artery with 80% stenosis.The lesion was pre-dilated with one non-medtronic balloon.One non-medtronic kissing balloon was used in the cx and another non-medtronic kissing balloon was used in the left anterior descending artery (lad) however the device was unable to cross.Post kissing using the non-medtronic balloons resulted in dissections in the proximal cx and lad.The device did not play a part in the dissections.The device did not pass through a previously deployed stent.No excessive force was used during delivery.The dissections were stented.The cx was stented with a different size onyx without issue.The device was inspected prior to use with no issue.The patient is alive.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: annex d code.Correction: pma / 510(k) # the lesion was pre-dilated with one 1.2x12mm non-medtronic balloon.One 3.0x12mm non-medtronic kissing balloon was used in the cx and another 3.5x12mm non-medtronic kissing balloon was used in the left anterior descending artery (lad).The cx was stented with a 2.75x30mm onyx.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: there were no issues with any stents placed.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: 23334800
• Report Number: 9612164-2025-05151
• Device Sequence Number: 15937182
• Product Code: NIQ
• UDI-Device Identifier: 00763000511388
• UDI-Public: (01)00763000511388(17)280217(10)0012674754(20)01
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 12/01/2025

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: ONYXNG27515UX
• Device Catalogue Number: ONYXNG27515UX
• Device Lot Number: 0012674754
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 10/22/2025; 11/28/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/07/2025; 12/01/2025
• Date Device Manufactured: 02/17/2025
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Weight: 105 KG