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

Model Number TF-23A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Aortic Insufficiency (1715); Inflammation (1932); Pulmonary Edema (2020); Pulmonary Regurgitation (2023); Cusp Tear (2656)

Event Date 10/23/2014

Event Type  Injury  

Event Description

A patient underwent aortic valve replacement with this sjm trifecta valve.The patient presented with aortic insufficiency, pulmonary edema and regurgitation.The annulus was repaired and the valve was replaced with another manufacturer's smaller 21mm bioprosthesis.During the explant procedure, a cuspal tear was observed.Inflammation was noted.The patient was recovering.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The results of this investigation concluded fibrous thickening of all cusps, a tear in cusp 1 and 2, inflow thrombus on cusps 1 and 2, thin layer of fibrin on cusp 3, outflow pannus on cusp 1, and nodular calcifications in cusps 2 and 3.Special stains were negative for organisms, and no acute inflammation was present.There was no evidence found to suggest the cause of the fibrin, pannus, calcification, thrombus and 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 fibrin, pannus, calcification, thrombus formation and cuspal tears remains unknown.

• 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: 4259695
• MDR Text Key: 4992248
• Report Number: 3008452825-2014-00046
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/29/2014

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: Other
• Device Expiration Date: 01/09/2014
• Device Model Number: TF-23A
• Device Lot Number: 3606596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 11/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2012
• 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: 68 YR