MAUDE Adverse Event Report: ST. JUDE MEDICAL ST. JUDE MEDICAL TRIFECTA TISSUE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TRIFECTA TISSUE HEART VALVE

Device Problem Product Quality Problem (1506)

Patient Problem Failure of Implant (1924)

Event Date 02/01/2022

Event Type  Injury  

Event Description

I had a st.Jude medical tf-23a valve placed in my chest on or about (b)(6) 2015 with an expected useful life of 12 - 15 years and it failed after year seven.My treating cardiologist and individuals at the valve clinic are aware of the failure of the original valve which has since been replaced by a tava valve.Thirty percent of the tf-23a valves seem to fail early supported by the following story: analysis of incidence and reasons for re-intervention after aortic valve replacement using the trifecta aortic bioprosthesis amir farda, zahid mahmoodb, sukumaran nairb, kasra shaikhrezaib, and nawwar al-attara,b,* from the a school of medicine, university of glasgow, glasgow, uk and b department of cardiothoracic surgery, golden jubilee national hospital, clydebank, scotland, uk.Abstract: trifecta bioprosthesis claims favorable hemodynamic performance.However, reports of structural valve deterioration (svd) raise concerns of its long-term durability.We assessed outcomes with the trifecta valve over a 10-year period.All patients receiving trifecta bioprostheses between october 2011 and october 2020 were included.Perioperative and survival characteristics were prospectively collated in an independent database.Re-intervention was recorded as a surrogate for svd.Nine hundred and forty-four patients (mean age 72.82 years § 8.13, 58% male) underwent aortic valve replacement with the trifecta valve.At 10-years, 1.4% of patients required a redo operation, giving an overall freedom from reintervention of 98.6%.The mean time to re-intervention was 48.87 months.Survival was 73.58% and 76.92% in patients who did not require re-intervention vs re-intervention group, respectively.In a large, single- center cohort, the trifecta aortic bioprosthesis had a 1.4% all-cause re-intervention rate at 10-years, with insignificant impact on survival.(curr probl cardiol 2022;00:101125.) declaration of interests: the authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.Curr probl cardiol 2022;00:101125 0146-2806/$ i see front matter https://doi.Org/10.1016/j.Cpcardiol.2022.101125.Curr probl.I have had multiple echo cardiograms of multiple types and really the earliest on in (b)(6) 2022 recommended a tvar replacement.Fda safety report id# (b)(4).

• Brand Name: ST. JUDE MEDICAL TRIFECTA TISSUE HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 14193752
• MDR Text Key: 290150237
• Report Number: MW5109287
• 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: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/28/2022
• Device Model Number: TRIFECTA TISSUE HEART VALVE
• Device Catalogue Number: TF-23A
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: BABY ASPRIN ; CALCIUM; CLOPIDOGREL AKA PLAVIX 75 MG ONCE /MORNING ; DRUG DOSE X PER DAY- TAMSULOSIN .40 MG ONCE AFTER BREAKFAST ; FUROSEMIDE 40 MG ONCE /MORNING ; LAMOTRIGINE 300 MG ONCE EVENING ; LEVOTHYROXINE .150 MG ONCE - EVENING ; MULTIDOSE VITAMIN ; NIFEDIPINE 30 MG ONCE - EVENING ; POTASSIUM CK 20 MEQ ER 20 MEQ ONCE /MORNING ; RESTASIS - MORNING ; SERTRALINE 100 MG ONCE - EVENING ; SIMVASTATIN 40 MG ONCE - EVENING ; TELMISARTAN 80 MG ONCE /MORNING ; VITAMIN D
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White