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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

The article, ¿5-years hemodynamic performance of three aortic bioprostheses.A randomized clinical trial¿, was reviewed.The article presented a prospective single-center experience to compare the hemodynamic performance quantified by in-vivo echocardiogram of 3 aortic prostheses.Devices included in this study were magna ease (48 pts), crown prt (51 pts), and trifecta (55 pts).The article concluded there were statistically significant differences in the hemodynamic performance between carpentier perimount magna ease and crown prt, and also between carpentier perimount magna ease and trifecta.Carpentier perimount magna ease showed the best hemodynamic performance at 5 years follow-up.Trifecta and crown prt prostheses were an independent risk factor for early structural valve degeneration.[the primary and corresponding author is lourdes montero cruces, department of cardiovascular surgery, clínico san carlos hospital, madrid, with corresponding email: l.Monterocr@gmail.Com] the time frame of the study was from 2014 to 2017 with 1-, 3-, and 5-years follow up after procedure.A total of 154 patients were included in this study.The average age was 76.5 years and the average gender was male.Comorbidities included hypertension, diabetes, smoking, dyslipidemia, copd, chronic kidney disease, prior elective surgery, prior cva, prior mi, severe aortic stenosis, severe aortic regurgitation there were no peri-procedural complications reported.Post-procedural complications included myocardial infarction, stroke (cerebrovascular event), structural valve degeneration, endocarditis, reintervention (surgical intervention and hospitalization).

Manufacturer Narrative

Summarized patient outcomes/complications of tissue valve implant, including trifecta valves were reported in a research article.Some of the complications reported were myocardial infarction, stroke, structural valve degeneration, endocarditis, surgical intervention and hospitalization; 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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 17510151
• MDR Text Key: 321714001
• Report Number: 2135147-2023-03504
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/11/2023
• 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): Required Intervention; Life Threatening; Disability; Hospitalization