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 Aortic Insufficiency (1715); Stroke/CVA (1770); Congestive Heart Failure (1783); Endocarditis (1834)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, between 28 february 2011 to 22 january 2018, 691 patients underwent aortic valve replacement, 331 were implanted with a trifecta valve and 360 were implanted with a carpentier edwards magna ease valve; events of congestive heart failure, moderate patient-prosthesis mismatch, stroke, structural valve degeneration, endocarditis, moderate to severe ai, elevated gradients and aortic valve 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.

Event Description

Related manufacturer reference number: 3008452825-2020-00675.The article, "early midterm results after valve replacement with contemporary pericardial prostheses for severe as" was reviewed.The research article is a retrospective single center experience to evaluate the clinical relevance of early hemodynamic differences with these two pericardial valves.Trifecta valve and magna ease valve were associated to the study.There is no allegation of malfunction of the abbott device.The article concluded that early hemodynamic benefits have not translated into differences in medium-term clinical outcomes between these two valves and long-term follow-up is necessary.The primary author and correspondence author of the article is fraser d.Rubens, md, divisions of cardiac surgery, university of ottawa heart institute with the email frubens@ottawaheart.Ca.

• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10924870
• MDR Text Key: 218920027
• Report Number: 3008452825-2020-00674
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2020
• 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