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

Model Number TFGT-19A

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

Patient Problems Anemia (1706); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Dyspnea (1816); Fever (1858)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.

Event Description

It was reported that on (b)(6) 2017, a 19mm trifecta¿ gt valve was implanted.On (b)(6) 2021, the patient was admitted to the emergency department due to dyspnea, fever, fatigue, anemia.The patient was transfused 1 united of packed red blood cells (prbc).The patient was diagnosed with pneumonia and was treated with rocephin.A transthoracic echocardiogram (tte) was performed and showed sever thickening and calcification on the av leaflets and severe aortic stenosis was also noted.It is unknown if the valve remains implanted.The status of the patient is unknown.Additional information has ben requested and is pending.

Manufacturer Narrative

An event of dyspnea, fever, fatigue, anemia, pneumonia, aortic stenosis, and thickening and calcification of the leaflets was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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
• MDR Report Key: 12024993
• MDR Text Key: 264454869
• Report Number: 3014918977-2021-00017
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018205
• UDI-Public: 05415067018205
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2019
• Device Model Number: TFGT-19A
• Device Catalogue Number: TFGT-19A
• Device Lot Number: 5928343
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 74