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

Model Number ONYXNG45012UX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Stenosis (2263); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event 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.There were no issues noted with the nc euphora balloons and launcher guide catheter used during the index procedure.Approximately 7 months post procedure the patient suffered a spontaneous st segment elevation myocardial infarction (stemi).The patient presented to the hospital with 3 days of stuttering substernal chest pressure that became constant, radiating from the right to left shoulder.The ae was associated with a myocardial infarction (mi) and was classified as a spontaneous mi in the territory of the target vessel.It was stated that the mi was related to to definite stent thrombosis in both stents.In stent restenosis was also noted in both stents.The event was treated with a clinically driven target lesion revascularization of the lmca and the circumflex artery (cx).During the re-vascularization, 1 onyx frontier stent, 3 nc euphora balloons,1 euphora balloon and 1 launcher guide catheter were used.The patient is recovering.The patient was taking dual antiplatelet therapy within 24 hours prior to the event.

• Brand Name: ONYX FRONTIER
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 18552442
• MDR Text Key: 333359862
• Report Number: 9612164-2024-00346
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00763000511722
• UDI-Public: 00763000511722
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/03/2024
• Date Device Manufactured: 09/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White