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

Model Number	ONYXNG25022UX
Medical Device Problem Codes	Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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 delivery at the lesion.The dislodged stent was not removed and was deployed in the lesion.No 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
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: the device was inspected before use with no issues.Negative prep/purging was performed on the device prior to use with no issues.T he lesion was pre-dilated with a compliant balloon.The left anterior descending (lad) artery was calcified.There was a previously deployed stent in the circumflex (cx) vessel which was hanging in the left main (lm).Resistance was noted advancing the device to the lesion.Excessive force was used.It is believed that the onyx frontier stent caught on the previously deployed stent in the cx.It was possible to get a small balloon inside the stent and dilate the stent.After the stent was deployed without injury to the patient, a non-medtronic intravascular lithotripsy (ivl) balloon was used to crack the calcium in order to appropriately expand the onyx frontier stent.No further patient complications have been reported as a result of this event.Sections b.1., b.2.And h.1.Updated.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.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: 21718001
• Report Number: 9612164-2025-01572
• Device Sequence Number: 9952624
• Product Code: NIQ
• UDI-Device Identifier: 00763000511319
• UDI-Public: 00763000511319
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/29/2025

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: ONYXNG25022UX
• Device Catalogue Number: ONYXNG25022UX
• Device Lot Number: 0012554341
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 03/28/2025; 05/28/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/15/2025; 05/29/2025
• Date Device Manufactured: 11/23/2024
• 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: Unknown