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

Model Number TFGT-19A

Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886); Material Split, Cut or Torn (4008)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient was originally managed by the department of cardiology in (b)(6) hospital, but an aortic valve replacement(avr) surgery using a 19mm trifecta gt valve was conducted in another hospital((b)(6) hospital) on (b)(6) 2018, due to aortic stenosis, regurgitation and calcification.The patient was carried to (b)(6) hospital due to heart failure last week, and a semi-emergency re-do avr was performed on (b)(6) 2021.The trifecta gt valve was explanted, replaced with a 17mm sjm regent heart valve w/flex cuff.The explanted valve was discarded because the valve became fully damaged during its explant.There was a tear beside the stent post between the rcc and the lcc.Pannus formation and fusion with the aortic wall were confirmed, also.The surgeon attributed the issue to the valve.The patient state is confirming.

Manufacturer Narrative

An event of stenosis, regurgitation, pannus, calcification and fusion to the aortic wall were reported.The torn leaflet 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; 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: 11732156
• MDR Text Key: 247509791
• Report Number: 3008452825-2021-00244
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2022
• Device Model Number: TFGT-19A
• Device Catalogue Number: TFGT-19A
• Device Lot Number: 6397949
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR