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

Model Number	ONYXNG45012UX
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Arrhythmia (1721); Atrial Fibrillation (1729); Chest Pain (1776); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Ischemia (1942); Myocardial Infarction (1969); Insufficient Information (4580)
Date of Event	06/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During the index procedure one resolute onyx drug eluting stent (des) was implanted in the mid left anterior descending artery (lad).Two nc euphora balloons and one euphora balloon were also used during the index procedure.Approximately 6 months post the index procedure the patient underwent a clinically driven target lesion revascularization procedure during which two onyx frontier des were implanted in the mid lad.Three nc euphora balloons and one launcher guide catheter were also used during this revascularization procedure.Approximately 17 months post the index procedure and 11 months post the revascularization procedure, the patient suffered from a non-st-elevation myocardial infarction (nstemi) and chest pain.The patient went to the emergency room for substernal chest pain that raised to the left shoulder, some shortness of breath and palpitations.The patient was noted to be in atrial fibrillation with rapid ventricular response (rvr) and with increasing troponins.The patient was diagnosed with a type 2 spontaneous myocardial infarction (mi) which was secondary to an ischemic imbalance.The mi occurred in the territory of the target vessel.The event was tr eated with a stent implanted in the mid lad, below the index procedure target lesion.The patient was hospitalized for two nights.The patient recovered.The patient was taking dual antiplatelet therapy within 24 hours prior to the event.The rationale for the relationship to the system or procedure was that it it was possible that the previous stent was not inflated all the way even though this lesion was treated previously as well and that it was difficult to know if it was due to the patients chronic disease or due to the previous stent.It was stated that the related stents were onyxng35018ux lot#: 0011666484, onyxng45012ux lot#: 0011545460 and ronyx30030ux lot#: 0010915501.
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.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: 20145016
• Report Number: 9612164-2024-04074
• Device Sequence Number: 20931872
• Product Code: NIQ
• UDI-Device Identifier: 00763000511722
• UDI-Public: 00763000511722
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2025
• Device Model Number: ONYXNG45012UX
• Device Catalogue Number: ONYXNG45012UX
• Device Lot Number: 0011545460
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/03/2024
• Date Device Manufactured: 12/11/2022
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 152 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White