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

Model Number	ONYXNG30038UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Chest Pain (1776); Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Two onyx frontier coronary drug-eluting stents were implanted to treat a lesion with >90% stenosis in the left anterior descending (lad) artery and the right coronary (rca) artery.The devices were inspected, with no issues noted.It was reported that after 24 hours post-stent implantation, acute stent thrombosis occurred.It was detailed that the patient developed chest discomfort and cardiac arrest and was ultimately resuscitated with the placement of a non-medtronic heart pumps device.Repeat angiography revealed stent thrombosis in the lad that was treated successfully with balloon angioplasty and more aggressive post-dilatation.The right coronary stent also had small amounts of thrombus, which were treated with aspiration thrombectomy and post-dilatation.The patient was reported to be alive with no further injury.
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: annex d code.Corrections: section b.2.Outcome attributed to adverse event.Section 7.8.Usage of device.Annex e codes.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: 19533172
• Report Number: 9612164-2024-02808
• Device Sequence Number: 12649809
• Product Code: NIQ
• UDI-Device Identifier: 00763000511531
• UDI-Public: 00763000511531
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 07/29/2024

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 Model Number: ONYXNG30038UX
• Device Catalogue Number: ONYXNG30038UX
• Device Lot Number: 0012174578
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/29/2024
• Date Device Manufactured: 03/05/2024
• 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: Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 77 KG