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

Model Number TF-23A

Device Problems Leak/Splash (1354); Torn Material (3024)

Patient Problem Chest Pain (1776)

Event Type  Injury  

Event Description

In (b)(6) 2011, an aortic valve replacement procedure was performed with this 23 mm sjm trifecta valve.Post procedure, the patient presented with acute chest pain and a reduction in hemodynamic performance.Echocardiography revealed leakage from one of the cusps.The valve was explanted (date unknown) and during the procedure, one of the cusps was noted to be torn.The valve was replaced with a 21 mm tissue valve from another manufacturer.The patient was reported to hemodynamically stable.Bacteriological examination result was negative.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The results of this investigation concluded tears in cusps 1 and 3 and fibrous pannus ingrowth on the outflow surface of cusp 1 and inflow surface of cusp 3.Fibrous pannus ingrowth and a thin layer of fibrin were found on the inflow and outflow surfaces of each cusp.There was no evidence of inflammation and gram stains were negative for organisms.No evidence was found to suggest the cause of the tears, fibrin and pannus was 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.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4488616
• MDR Text Key: 5504023
• Report Number: 3007113487-2015-00001
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P100029
• 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: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2012
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 3260899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2010
• 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: 75 YR