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

Catalog Number TFGT-23A

Device Problem Degraded (1153)

Patient Problems Angina (1710); Arrhythmia (1721); Cardiac Arrest (1762); Stroke/CVA (1770); Dyspnea (1816); Fatigue (1849); Renal Failure (2041); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/16/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Medwatch mw5146858.I began feeling "toxic" sick on (b)(6) 2023, and developed shortness of breath, severe central/ obstructive sleep apnea, heart arrythmias and fatigue.My cardiologist began following me with more frequent echocardiograms, as i had an abbott trifecta aortic valve placed at (b)(6) clinic on (b)(6) 2018.My kidney function decreased, i was diagnosed with diastolic heart failure, and was told the valve was going to need replacement "sooner than later".On (b)(6), i received a letter from (b)(6) clinic stating that the artificial valve they had used was defective.I promptly took this letter to my cardiologist who began making a plan for my care based on this new knowledge.On (b)(6), i went to er with chest pain, had an emergency heart catheterization which showed the valve still in place and within a few hours my family was informed the valve had exploded and i had 10 percent heart function.I was coded and transferred to icu, and then transferred to (b)(6) hospital on (b)(6).Under the care of two cardiac surgeons, they performed an emergency tavr, which is not normally done under emergency circumstances, but they explained to my family i wouldn't survive open heart surgery.I was told they worked on me 4 hours and ran into unexpected problems to solve along the way.My family was braced with a good chance i would not survive as i coded 3 times total.I was kept alive on the ventilator, dialyzed with kidney machine for several days in icu following the surgery.I was discharged from hospital approx.17 days later.I suffered a mild stroke at some point in my hospitalization.I was told that the trifecta abbott valve "imploded".Many good doctors and health care professionals worked to save my life.My kids and grandkids and me were severely traumatized.I am home now, have been for six weeks.Considering, i am doing well.I ask for your prompt attention in warning others about what can happen if this malfunctioning valve is not addressed before it causes life threatening issues.I have a replaced artificial aortic valve in place.It was reported that in 2018, a trifecta valve was implanted.In 2023, the patient developed dyspnea, severe central/obstructive sleep apnea, heart arrhythmias, fatigue, decreased kidney function, and diastolic heart failure.Following-up echocardiograms occurred with a cardiologist who recommended the trifecta valve be explanted sooner rather than later.On (b)(6) 2023, the patient received a letter from the implanting clinic stating that the implanted trifecta was defective.On (b)(6) 2023, the patient went to the emergency room with chest pain.Imaging showed that the trifecta valve had "exploded" and the patient had 10% heart function.The patient was transferred under the care of cardiology where they performed an emergency trans aortic valve replacement (tavr) because the patient was not a suitable candidate for open heart surgery.The surgery took four hours and unexpected problems occurred during the procedure causing the patient to code three times.After the procedure the patient was ventilated and kept on a dialysis machine for several days in the intensive care unit (icu).A mild stroke occurred at some point in the hospitalization.Approximately 17 days later the patient was discharged.No additional information was provided.

Manufacturer Narrative

An event of the patient having dyspnea, severe central/obstructive sleep apnea, heart arrhythmias, fatigue, decreased kidney function, and diastolic heart failure about five years after the valve was implanted and replacement of the device with a valve in valve due to the valve having "imploded" was reported.A more comprehensive assessment, including histopathological examination of the valve tissue, could not be performed as the device remains implanted and was not returned for analysis.The device serial number was not provided, and therefore the device history record could not be reviewed.No additional information on the specific failure of the valve or additional patient information was able to be obtained.Factors that may cause or contribute to valve deterioration include implant-related factors, biological factors, and patient-related factors, none of which could be confirmed in this case.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.

• Brand Name: TRIFECTA¿ GT VALVE
• Type of Device: 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: 18183824
• MDR Text Key: 328742505
• Report Number: 2135147-2023-05120
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: 05415067018229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TFGT-23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Female