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

Model Number TF-23A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Insufficiency, Valvular (1926); Unspecified Infection (1930); Pseudoaneurysm (2605); Fibrosis (3167)

Event Date 08/14/2014

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

According to an article "pseudo-aneurysm of mitral aortic intervalvular fibrosa after avr" (literature id 1601w2-060h, published in the japanese society for cardiovascular surgery 2015, vol.44, pp.334-337); a 23mm trifecta valve was implanted on (b)(6) 2014 secondary to aortic regurgitation.The valve functioned well by echo and the patient was discharged 21 days post-implant.The crp blood test result was 1.99mg/dl.During an outpatient follow-up on (b)(6) 2014, a diastolic murmur and cardiac t enlargement with chest - thoracic ratio of 50.2% were reported.A transthoracic echo (tte) revealed severe paravalvular leak and the diagnosis was an infection of the prosthesis requiring hospitalized.On (b)(6) 2014, a contrast ct confirmed mitral aortic intervalvular fibrosa (maif) and multiple pseudoaneurysms at the level of the left ventricular outflow tract (lvot) inferior to the aortic valve.On (b)(6) 2014, this trifecta valve was explanted and replaced with a 21mm non-sjm tissue valve.On (b)(6) 2014, the crp blood test result was 7.61mg/dl.Antibiotic therapy was initiated and cultures were negative 30 days post- procedure.The patient was discharged 50 days post-operatively with antibiotic therapy.A repeat tte confirmed good heart and valve function.Causal bacteria was not identified.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5376470
• MDR Text Key: 36257546
• Report Number: 3007113487-2016-00008
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2016

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: Physician
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2016
• Initial Date FDA Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 50