MAUDE Adverse Event Report: MEDTRONIC MEXICO EUPHORA RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,

Model Number	EUP2515X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Myocardial Infarction (1969)
Date of Event	02/23/2024
Type of Reportable Event	Death
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.
Event or Problem 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 before 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.

• Brand Name: EUPHORA RX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18947598
• Report Number: 9612164-2024-01351
• Device Sequence Number: 8052240
• Product Code: LOX
• UDI-Device Identifier: 00643169560024
• UDI-Public: 00643169560024
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K143480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 03/21/2024

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: 11/12/2025
• Device Model Number: EUP2515X
• Device Catalogue Number: EUP2515X
• Device Lot Number: 227736288
• 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: 02/24/2024
• Initial Report FDA Received Date: 03/21/2024
• Date Device Manufactured: 11/13/2023
• 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; Death
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White