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

Model Number	ONYXNG27518UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: the lesion being treated had mild tortuosity and 85% stenosis and was the ostium of the right posterior descending (r-pda) artery.R esistance was not noted during withdrawal of the device.All the stent equipment, the cath lab and all rubbish was searched for the missing stent.It is not possible that the stent dislodged during sheath removal before insertion in the patient.A non-medtronic stent was used to complete the procedure.Patient gender provided.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 is no complaint against the other medtronic devices used during the procedure.Image analysis: review of the procedural images provided confirm the presence of a severely stenotic lesion in rca.Pre-dilation of the lesion can be observed, with improved vessel patency visible following balloon dilation.Attempted delivery and dislodgement of the medtronic stent is not captured in the images provided.Delivery of a stent, presumably the non-medtronic second stent, to the lesion can be observed, followed by successful expansion and deployment.Improved vessel patency can be observed following stent deployment.A series of images of the patient's limbs and skull were also received; however, the dislodged stent cannot be observed anywhere in the patient's vasculature.Correction: annex a code.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 one onyx frontier coronary drug eluting stent dislodged after removal from the patient. the lesion being treated was the ostium of the right posterior descending (r-pda) artery.The device was inspected prior to use with no issues. the lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device in the proximal right coronary artery (rca).Excessive force was not used during delivery.After resistance was felt an attempt was made to remove stent back into the 6f guide and out of the body.When the stent delivery system (sds) was removed out of the sheath the stent was missing. imaging was conducted on the patient's arms, legs, and aorta, but the stent was never found.The patient was fine overnight and was discharged the following day.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
Additional information: it was later reported that during the percutaneous coronary intervention, as the stent was introduced down the right coronary artery (rca) to be placed in the affected area, the stent dislodged from the balloon without being deployed.The patient remained hemodynamically stable.Post procedure the patient underwent an echo and was admitted for observation.The stent was unable to be located.The patient did not develop any signs or symptoms of injury.Section a.Patient information 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.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 lesion was pre-dilated with a 2.25x12mm euphora balloon inflated to 12 atm, and 14 atm for 20seconds.As the stent was attempted to be withdrawn and readvanced, the stent came off the balloon easily.In the process of readvancing the balloon into the stent over the wire, the balloon and stent prolapsed into the aorta.The stent was no longer seen in the rca.The dislodged stent was not in the guide catheter on checking.A 5f dxterity diagnostic catheter and two 6f launcher guide catheters were also used during the procedure.Patient initials and date of birth provided.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: 21736527
• Report Number: 9612164-2025-01620
• Device Sequence Number: 9002375
• Product Code: NIQ
• UDI-Device Identifier: 00763000511395
• UDI-Public: 00763000511395
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup,Followup
• Report Date (Section B): 06/18/2025

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: ONYXNG27518UX
• Device Catalogue Number: ONYXNG27518UX
• Device Lot Number: 0012483445
• 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: 03/18/2025
• Supplement Date Received by Manufacturer: 04/09/2025; 04/23/2025; 03/27/2025; 06/09/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/15/2025; 04/30/2025; 05/29/2025; 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White