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

Model Number TF-23A

Device Problem Missing Information (4053)

Patient Problems Aortic Valve Stenosis (1717); Heart Failure (2206)

Event Type  Injury  

Manufacturer Narrative

An event of structural valve deterioration and stenosis was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.Information from the field indicated that the patient had a medical history that included chronic kidney disease, hemodialysis and native aortic valve stenosis.

Event Description

The following information was obtained from the professional literature of (b)(6) (id# (b)(4)).A 23mm trifecta valve was implanted in a (b)(6) man with a history of chronic kidney disease, hemodialysis and native aortic valve stenosis.A year and 8 months post-implant, the patient presented with structural valve deterioration and aortic stenosis.The patient decompensated rapidly and intervention was required for the heart failure.The patient was started on catecholamine and aortic balloon-pumping was performed; however, the chest pain could not be suppressed.Balloon aortic "valvuoloplasty" was performed as the patient was too high risk for a re-do aortic valve replacement.After the "valvuoloplatsy", the heart failure was stabilized and the a re-do aortic valve replacement was planned.Three months later, the valve was explanted and replaced with another valve (model and size unknown).Additional information is not available.

• 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, costa rica 1897- 4050; 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, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8173349
• MDR Text Key: 130625391
• Report Number: 3008452825-2018-00422
• 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: 12/18/2018

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 Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/18/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 50 YR