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

Model Number TF-21A

Device Problem Detachment Of Device Component (1104)

Patient Problems Aortic Insufficiency (1715); Dyspnea (1816); Mitral Insufficiency (1963); Pulmonary Edema (2020)

Event Date 08/06/2014

Event Type  Injury  

Event Description

The information provided to sjm indicated the patient underwent a double valve replacement procedure on (b)(6) 2012.This 21 mm sjm trifecta¿ valve was implanted in the aortic position and a 29 mm sjm epic¿ stented tissue valve was implanted in the mitral position.Postoperative course was characterized by implant of an sjm accent pacemaker.On (b)(6) 2014, the patient presented to the hospital with dyspnea, was treated with diuretic therapy, and was discharged.The patient presented to the hospital again on (b)(6) 2014 with severe pulmonary edema and was hospitalized.Transesophageal echocardiography revealed aortic insufficiency due to improper coaptation of the left coronary cusp.The mitral valve also showed transvalvular mitral insufficiency.The patient underwent a re-do double valve replacement procedure on (b)(6) 2014.During the explant procedure, the cusp corresponding to the left coronary sinus of this aortic trifecta¿ valve was found to be detached near the annulus.One cusp of the mitral epic¿ stented tissue valve (medwatch report# 3001883144-2014-00018) was found to be prolapsed.A 27 mm bioprosthetic valve from another manufacturer was implanted in the mitral position and a 21 mm bioprosthetic valve from another manufacturer was implanted in the aortic position.The patient was reported to be stable postoperatively.

Manufacturer Narrative

(b)(4).The results of this investigation concluded the presence of fibrous thickening on all cusps, fibrous pannus ingrowth on inflow surface of cusp 1, a thin layer of fibrin on all cusps, and tears on cusps 2 and 3.Special stains were negative for organisms, and no acute inflammation or significant calcifications were present.There was no evidence found to suggest the cause of fibrin, pannus, and tear were due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the fibrin, pannus, and tear remains unknown.

• Brand Name: TRIFECTA¿ VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4061742
• MDR Text Key: 4809560
• Report Number: 3008452825-2014-00034
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PP100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/06/2014

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 Expiration Date: 03/21/2014
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 3676316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 09/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2012
• 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; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 85