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

Model Number	ONYXNG45012UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Stenosis (2263); Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During the index procedure two onyx frontier drug eluting stents were implanted in the left main coronary artery (lmca) and in the left anterior descending artery (lad).During the index procedure 6 nc euphora balloons and 1 launcher guide catheter were also used.Approximately 7 months post the index procedure the patient underwent a clinically driven target vessel revascularization of the lcma and the cx to treat in stent restenosis during which one onyx frontier stent was implanted.During this revascularization 3 nc euphora balloons,1 euphora balloon and 1 launcher guide catheter were also used.Approximately 16 months post the index procedure and 8 months post the revascularization procedure, the patient suffered from intermittent chest pain.The patient went to emergency department after the chest pain worsened and underwent cardiac catheterization.It was stated that there was possible restenosis.Stent thrombosis was confirmed by angio in the onyx frontier stent.The event was treated with hospitalization and a surgical procedure - cardiac catheterization used for diagnostic purposes.The patient has not recovered.The patient was taking dual antiplatelet therapy within 24 hours prior to the 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: the site confirmed the event was related to the onyx frontier stents.Correction: during the index procedure the proximal left anterior descending artery was treated.The clinically driven target vessel revascularization was performed in the proximal circumflex (cx).It was stated that there was possible restenosis of distal left main and ostial left circumflex.Device lot details 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: 20381377
• Report Number: 9612164-2024-04532
• Device Sequence Number: 20451305
• Product Code: NIQ
• UDI-Device Identifier: 00763000511722
• UDI-Public: 00763000511722
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2025
• Device Model Number: ONYXNG45012UX
• Device Catalogue Number: ONYXNG45012UX
• Device Lot Number: 0011427826
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 11/23/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 12/06/2024
• Date Device Manufactured: 09/29/2022
• 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: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White