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

Model Number TF-25A

Device Problems Break (1069); Torn Material (3024)

Patient Problem Aortic Insufficiency (1715)

Event Date 10/31/2014

Event Type  Injury  

Event Description

The patient presented with dyspnea and was found to have aortic insufficiency.The valve was explanted and a tear was observed.It was reported a clamp used during explant may have damaged the valve stent.A 23 mm bioprosthesis from another manufacturer was implanted.Postoperatively, the patient's condition was reported to be good.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The results of this investigation concluded fibrous thickening of cusp 2, fibrous pannus ingrowth on the inflow surface of all cusps, tears in all three cusps, a thin layer of fibrin on the outflow surface of cusp 3, and focal outflow thrombus on the base of cusp 1.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 thrombus formation 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 fibrin, pannus and 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 ; 6517565400
• MDR Report Key: 4289730
• MDR Text Key: 5083041
• Report Number: 3008452825-2014-00049
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2013
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 3457121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2011
• 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: 72 YR