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

Model Number TF-19A

Device Problems Gradient Increase (1270); Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Chest Pain (1776); Endocarditis (1834); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Chills (2191)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2014, a 19mm trifecta valve was implanted.The patient presented with chills, night sweats, fatigue, chest pain, endocarditis and systemic hypertension.During follow-up, increase gradient and stenosis was reported.On (b)(6) 2020, the valve was explanted and replaced with an inspiris resilia 19mm valve.The patient was reported to be in stable condition.Additional information was requested but cannot be obtained.

Manufacturer Narrative

Additional information: h6.An event of endocarditis, systemic hypertension, chills night sweats, fatigue, chest pain, increase in gradient, stenosis, and replacement of the valve was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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 01897 -405; CS 01897-4050
• MDR Report Key: 9949674
• MDR Text Key: 187266038
• Report Number: 3008452825-2020-00195
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TF-19A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 80