MAUDE Adverse Event Report: ABBOTT MEDICAL TRIFECTA¿ GT VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number	TFGT-21A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Ischemia (1942); Pain (1994)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event date was estimated as 01 january 2021 as it was reported to have occurred on an unknown date in the year 2021.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
User facility medwatch report mw5160636 received that states, "i had an abbott trifecta valve placed on (b)(6) 2019.I had improved health immediately after.However, in or around 2021, i began having increased shortness of breath and other symptoms.These continued to escalate over the next 3 years.I was hospitalized numerous times, sometimes for a month at a time.I had numerous painful medical procedures done.I had decreased blood flow which caused several problems including decreased healing (i underwent a lower leg amputation in 2022), an ischemic bowel/intestines which caused a nearly fatal chrons flare; i coded twice requiring cpr; i was airlifted from (b)(6) to (b)(6) for treatment; i had several ambulance transports; i required both in-patient and outpatient treatment and at-home care.Twice, i was told to get my affairs in order because i needed cardiac procedures that were extremely high risk.This has been a terrifying and costly experience for both me and my family.My doctor told me the heart valve used has been recalled and needed to be replaced.After three years of hell, i underwent a valve-in-value procedure and feel better but i am still recovering from all the medical trauma."successful 23 core valve for failed 21 trifecta residual gradient over 20 mm hg despite high pressure inflations due to limitations of the 21 trifecta valve (baseline gradient was 15 mm hg post surgery)."" it was reported that on (b)(6) 2019, a 21mm trifecta gt valve was implanted during an aortic valve replacement.In 2021, the patient began having shortness of breath and other symptoms, which worsened over the next 3 years.The patient was hospitalized numerous times and had numerous medical procedures performed.The patient reportedly had decreased blood flow, which caused several problems including decreased healing, lower leg amputation, ischemic intestines, and crohn's flare.The valve had a residual gradient of over 20mmhg.In 2024, the patient had a valve-in-valve procedure with a 23mm non-abbott valve.The patient status was stable.
Additional Manufacturer Narrative
An event of aortic valve stenosis, dyspnea, ischemia, pain, hospitalization, and surgical intervention was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.Based on the limited information, the cause of the reported aortic valve stenosis could not be conclusively determined.The reported dyspnea, ischemia, pain appear to be a cascading effect of the aortic valve stenosis.The reported hospitalization and surgical intervention were results of case-specific circumstances as the patient was admitted and underwent a valve-in-valve procedure.

• Brand Name: TRIFECTA¿ GT VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20820482
• Report Number: 2135147-2024-06079
• Device Sequence Number: 7636990
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: (01)05415067018212(17)220704(10)BR00017471
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/04/2022
• Device Catalogue Number: TFGT-21A
• Device Lot Number: BR00017471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2018
• 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; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White