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

Catalog Number UNK SJM TRIFECTA VALVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Valve Stenosis (1717); Stroke/CVA (1770); Unspecified Infection (1930); Transient Ischemic Attack (2109); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 06/01/2014

Event Type  Injury  

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.The additional patient effects of death and malfunctions reported in the article are captured under separate medwatch reports.Summarized patient outcomes/complications of trifecta valve in middle age population with small aortic annuls were reported in a research article "mid-term clinical and hemodynamic outcomes in middle age patients post trifecta¿ (abbott) aortic valve replacement: a single-center study" in a subject population with multiple co-morbidities including smoking, hypertension, diabetes mellitus, dyslipidemia, chronic obstructive pulmonary disease, cancer, renal failure, peripheral vascular disease including deep vein thrombosis and left iliac and renal embolization, prior cerebrovascular accident, chronic atrial fibrillation, myocardial infarction, angina, coronary artery disease, prior cardiac procedures, heart failure.Some of the complications reported were death, surgical intervention (surgical explant, valve-in-valve), hospitalization (30-day readmission), transient ischemic attack, cerebrovascular accident, atrioventricular block, infection, aortic stenosis, aortic regurgitation, paravalvular leak; these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

Event Description

The article, "mid-term clinical and hemodynamic outcomes in middle age patients post trifecta¿ (abbott) aortic valve replacement: a single-center study", was reviewed.The article presented a retrospective, single center study on the mid-term clinical and hemodynamic performance of trifecta valve in middle age population with small aortic annuls.The only device included in this study was trifecta valve.The article concluded excellent mid-term durability, clinical and hemodynamic performance of the trifecta valve in middle age population, despite the fact of non-statically significant trend-up of transvalvular gradient over the follow up period.Further long-term studies with larger sample-size are warranted to confirm these results.[the primary and corresponding author was mohammed al aboud, adult cardiac surgery section, heart center, king faisal specialist hospital and research centre, riyadh, saudi arabia, with corresponding email: : mohd.Alaboud@gmail.Com].The time frame of the study was from june 2014 to december 2019 with last follow up on (b)(6) 2023.A total of 24 patients were included in this study, of which all received an abbott device.The average age was 47 years and there was no majority gender (evenly divided out of 24 patients).Comorbidities included smoking, hypertension, diabetes mellitus, dyslipidemia, chronic obstructive pulmonary disease, cancer, renal failure, peripheral vascular disease including deep vein thrombosis and left iliac and renal embolization, prior cerebrovascular accident, chronic atrial fibrillation, myocardial infarction, angina, coronary artery disease, prior cardiac procedures, heart failure.

• Brand Name: SJM TRIFECTA 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: 19187896
• MDR Text Key: 341117098
• Report Number: 2135147-2024-01848
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SJM TRIFECTA VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Life Threatening; Disability; Required Intervention