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

Model Number ONYXNG30038UX

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

Patient Problems Cardiac Arrest (1762); Myocardial Infarction (1969)

Event Date 02/23/2024

Event Type  Death  

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.

Event Description

During the index procedure two onyx frontier coronary drug eluting stents were implanted in the left anterior descending artery (lad).One launcher guide catheter, one euphora balloon catheter, five nc euphora balloon catheters, and one telescope guide extension catheter (gec) were also used during the procedure.No complications were reported during the procedure.On the same day post procedure the patient suffered from a spontaneous myocardial infarction (mi) and cardiac arrest / sudden cardiac death.The patient was doing well after the procedure, had eaten dinner and everything was normal when suddenly the patient collapsed on the ground.The patient did not have any symptoms of chest pain, diaphoresis, nausea, or vomiting.Advanced life saving measures were utilized.Emergency medical services (ems) was contacted and a family member tried to do some mouth-to-mouth until the ambulance arrived.When the ambulance arrived, they detected electromechanical dissociation (emd) and started cardiopulmonary resuscitation (cpr) for 30 minutes bef ore the patient arrived to the emergency room (er).Additional cpr was performed, however, this was unsuccessful in obtaining blood pressure.The patient was taking dual antiplatelet therapy within 24 hours prior to the event.The event was not treated.During the 4 years prior to being diagnosed with coronary artery disease (cad), the patient had atypical pain and tended to have chest pain only at rest.It was only recently that the patients symptoms were more frequent, more severe and occurring with exertion.This led to repeating the computerized tomography (ct) of the coronary arteries and severe disease was noted after the second diagonal.

Manufacturer Narrative

Correction: d.Suspect medical device, 6a: implanted date added.Annex b code 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.

• Brand Name: ONYX FRONTIER
• Type of Device: 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: 18947606
• MDR Text Key: 338184326
• Report Number: 9612164-2024-01352
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00763000511531
• UDI-Public: 00763000511531
• 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,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ONYXNG30038UX
• Device Catalogue Number: ONYXNG30038UX
• Device Lot Number: 0011965528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2024
• Date Device Manufactured: 09/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White