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

Model Number TFGT-23A

Device Problems Backflow (1064); Biocompatibility (2886); Material Split, Cut or Torn (4008)

Patient Problems Corneal Pannus (1447); Abscess (1690); Aortic Regurgitation (1716); Endocarditis (1834); Cusp Tear (2656)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2019, a 23mm trifecta¿ gt valve was implanted in the patient due to tight calcified aortic stenosis.In (b)(6) 2020, the patient experienced a large aortic leak without vegetation which lead to hospital care.On (b)(6) 2020, the valve was explanted from the patient due to endocarditis and was replaced with a 21mm magna ease valve.During the procedure, a large abscess in the wall was noted requiring antibiotic treatment.It was also discovered that the bioprosthesis was perforated.There was an incomplete, but very long tear along the prosthesis' commissure located between the left coronary sinus and non-coronary sinus.There was also a large pannus noted under the bioprosthesis.The surgery was successfully completed with stable hemodynamics and it was reported that the patient is currently stable.

Manufacturer Narrative

Additional information for: g3, g6, h2, h6, and h10.The reported event of aortic leak, endocarditis, pannus, prosthesis tear, and valve explant could not be confirmed.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 (SH); 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: 11098856
• MDR Text Key: 224518329
• Report Number: 3008452825-2020-00734
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: 05415067018229
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2022
• Device Model Number: TFGT-23A
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 6767970
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR