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

Model Number TFGT-21A

Device Problems Calcified (1077); Obstruction of Flow (2423)

Patient Problems Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758)

Event Type  Death  

Event Description

It was reported that in 2021, a 21 mm trifecta gt valve was explanted after being implanted for less than 4 years.The patient had a very high gradient, 60 mmhg, and severe symptoms of stenosis associated with this event.It was observed on explant that the device had severely calcified leaflets.The device was replaced with another 21 mm trifecta gt valve to resolve this event.It was reported that the patient did not recuperate from the operation, and the patient died 3 weeks after the procedure.The physician is surprised by the leaflet calcification with a patient over 70 years old.No additional information was provided.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Manufacturer Narrative

Additional information: g3, g6, h2, h6, h10.An event of explant of the valve due to calcification on the valve leaflets with a high gradient and stenosis was reported.Also reported was that the patient did not recuperate from the replacement procedure and died 3 weeks later.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: TRIFECTA¿ GT 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
• 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 01897 -405; CS 01897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13059106
• MDR Text Key: 282607073
• Report Number: 3014918977-2021-00123
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TFGT-21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2021
• 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): Death