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

Lot Number 13857137

Device Problem Insufficient Information (3190)

Patient Problem Sepsis (2067)

Event Type  Injury  

Event Description

Medtronic received information that at an unknown date in 2018, this patient received a valve-in-valve procedure.The original bioprosthetic valve (trifecta) was implanted (b)(6) 2013.This patient developed sepsis, which the site related to the recent valve-in-valve procedure.No mention of endocarditis.No additional adverse patient effects were reported.(b)(4).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
• MDR Report Key: 17522409
• MDR Text Key: 321136523
• Report Number: MW5129357
• 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: 07/12/2018

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
• Device Lot Number: 13857137
• Patient Sequence Number: 1