MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (SH) TRIFECTA STENTED TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

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

Patient Problems Arrhythmia (1721); Embolism (1829); Endocarditis (1834); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturing reference number: 3008452825-2021-00006 the article, "structural valve deterioration after aortic valve replacement with the trifecta valve", was reviewed.The research article is retro- and prospective single center cross-sectional study to assess the rates of structural valve deterioration(svd) and associated reintervention in patients undergoing surgical aortic valve replacement (savr) with the trifecta valve.The article concluded rates of svd after aortic valve replacement with the first generation trifecta and that studies with longer follow up of the second generation trifecta valve are needed to assess if changes in design positively impacted svd rates of the first generation.The primary and corresponding author is paul werner, md, division of cardiac surgery, department of surgery, medical university of vienna, waehringer guertel 18-20, 1090 vienna, austria.With the email paul.Werner@meduniwien.Ac.At.

Manufacturer Narrative

As reported in a research article, 347 consecutive patients underwent surgical aortic valve replacement with a trifecta valve between 2011 and 2017; events of bleeding, structural valve deterioration, arrhythmia, embolism, endocarditis, and re-intervention were reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: TRIFECTA STENTED TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (SH); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• MDR Report Key: 11152201
• MDR Text Key: 226234567
• Report Number: 3008452825-2021-00007
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 02/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR