MAUDE Adverse Event Report: ST. JUDE MEDICAL / ABBOTT MEDICAL TRIFECTA GT TISSUE HEART VALVE; HEART VALVE, MECHANICAL

Model Number TFGT-27A

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 01/12/2017

Event Type  Injury  

Event Description

Had a st jude / abbott trifecta aorta heart valve done on me in open heart surgery.Was told minimum 8 year life span, and as high as 15 seen.After one year i was still not recovering completely as also told would take, so began complaining to my cardiologist.After many medication changes, and subsequent tests, was determined the valve was faulty.I had a new valve put in place (b)(6) 2019.This is far too short life of such a critical device.Fda safety report id# (b)(4).

• Brand Name: TRIFECTA GT TISSUE HEART VALVE
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL / ABBOTT MEDICAL
• MDR Report Key: 8936149
• MDR Text Key: 156259739
• Report Number: MW5089353
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TFGT-27A
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 61 YR
• Patient Weight: 68