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

Model Number TFGT-23A

Patient Problems Apnea (1720); Arrhythmia (1721); Stroke/CVA (1770); Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Failure of Implant (1924); Ventilator Dependent (2395); Sleep Dysfunction (2517); Heart Failure/Congestive Heart Failure (4446); Renal Impairment (4499)

Event Date 08/16/2023

Event Type  Injury  

Event Description

I began feeling "toxic" sick in (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 in (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 july 27th 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 august 16th, 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 in (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.

• Brand Name: TRIFECTA GT TISSUE HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 17923928
• MDR Text Key: 325737561
• Report Number: MW5146858
• Device Sequence Number: 1
• Product Code: LWR
• 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: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: TFGT-23A
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: BABY ASA.; BRILINTA.; CELEXA.; HYDRALAZINE.; HYDROCORTISONE FOR ADRENAL INSUFFICIENCY.; LASIX.; METOPROLOL.; POTASSIUM.; SYNTHROID.; VIT B12.; VIT D. ; XANAX FOR SLEEP.
• Patient Outcome(s): Required Intervention; Hospitalization; Other; Disability; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White