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

Catalog Number UNK SJM TRIFECTA VALVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Endocarditis (1834); Shock (2072)

Event Date 01/01/2011

Event Type  Injury  

Event Description

The "trifecta family of valves real-world evidence study" was reviewed.This clinical study is leveraging real-world data to assess clinical outcomes following surgical aortic valve replacement (savr) with abbott¿s trifecta family of valves amongst a large u.S.Nationwide sample.Devices included were trifecta (23,197) and trifecta gt (9,440).The study concluded similar survival and freedom from reintervention for the trifecta valve and trifecta gt valve cohorts through 6-years of follow-up.In the rwe study the peak time to reintervention was 6 years for the trifecta valve cohort and 3 ears for the trifecta gt valve cohort.The 30-day survival with reintervention using a transcatheter valve-in-valve was better than with reintervention with repeat savr.However, the higher 30-day mortality with repeat savr may be influenced by having additional concomitant surgical procedures performed and endocarditis is some patients.Top predictors for trifecta valve reintervention included female, obesity, small valve size, and younger age.The time frame of the study was from (b)(6) 2011 to(b)(6) 2021.A total of 32,637 patients were included in this study.The average age was 75.2 years for patients in the trifecta group and 73.4 years for patients in trifecta gt group.The average gender was male.Comorbidities included hypertension, cerebrovascular disease, peripheral vascular disease, chronic pulmonary disease, diabetes, heart failure, atrial fibrillation, obesity, renal failure, dialysis, prior myocardial infarction, coagulopathy, liver disease, and endocarditis.Peri-procedural complications diagnosis of cardiogenic shock, acute mechanical circulatory support (mcs).Post-procedural complications included 30-day mortality (death), endocarditis, surgical intervention, hospitalization.

Manufacturer Narrative

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

Manufacturer Narrative

Summarized patient outcomes/complications of trifecta valve were reported in a research article in a subject population with multiple co-morbidities including hypertension, cerebrovascular disease, peripheral vascular disease, chronic pulmonary disease, diabetes, heart failure, atrial fibrillation, obesity, renal failure, dialysis, prior myocardial infarction, coagulopathy, liver disease, and endocarditis.Some of the peri-procedural complications reported were cardiogenic shock and acute mechanical circulatory support endocarditis, post-procedural complications reported were surgical intervention, hospitalization and patient death.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.

• 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: 18166034
• MDR Text Key: 328480648
• Report Number: 2135147-2023-05075
• Device Sequence Number: 1
• Product Code: LWR
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SJM TRIFECTA VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• 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): Hospitalization; Death; Required Intervention; Life Threatening