MAUDE Adverse Event Report: ST. JUDE MEDICAL TRIFECTA; HEART-VALVE, MECHANICAL

Device Problem Insufficient Information (3190)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Death  

Event Description

Medtronic received information that during the implant of a transcatheter bioprosthetic valve into a st.Jude trifecta valve, the trifecta valve caused an occlusion in the left main coronary artery.The patient expired.(b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TRIFECTA
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17537364
• MDR Text Key: 321041074
• Report Number: MW5144243
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1