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

Model Number TF-25A

Device Problem Torn Material (3024)

Patient Problems Aortic Insufficiency (1715); Laceration(s) (1946); Pneumonia (2011); Heart Failure (2206)

Event Date 11/06/2014

Event Type  Injury  

Event Description

A patient was implanted with a 25mm sjm trifecta valve on (b)(6) 2014.Several months post-surgery, the patient presented at an outlying community hospital with suspected pneumonia.Positive blood cultures were associated with pneumonia.The patient was treated and discharged.The patient was subsequently readmitted for heart failure and aortic insufficiency.A re-do aortic valve replacement was performed for suspected endocarditis.At explant, the surgeon observed a clean valve with no evidence of endocarditis, however there was a distinct tear at the suture line in the area of one of the struts.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4) - aortic insufficiency; torn material.The results of this investigation concluded tears were observed in all three cusps.All cusps were fibrotically thickened and contained a thin layer of fibrin.There was fibrous pannus ingrowth on the inflow surface of cusps 1 and 2, which narrowed the inflow diameter to 15 mm.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 the fibrin, pannus, and cuspal tears 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 reported event remains unknown.

Event Description

A patient was implanted with a 25mm sjm trifecta valve on (b)(6) 2013.Several months post-surgery, the patient presented with suspected pneumonia.Positive blood cultures were associated with pneumonia.The patient was treated and discharged.The patient was subsequently readmitted for heart failure and aortic insufficiency.A re-do aortic valve replacement was performed for suspected endocarditis on (b)(6) 2014.At explant, the surgeon observed a clean valve with no evidence of endocarditis; however, there was a distinct tear at the suture line in the area of one of the stent posts.A 23 mm sjm trifecta valve was successfully implanted.

• Brand Name: SJM 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 ; 6517564470
• MDR Report Key: 4290424
• MDR Text Key: 5081584
• Report Number: 3008452825-2014-00050
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2014

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: 03/12/2014
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 3657286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/11/2015; 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2012
• 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: 69 YR