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

Model Number TFGT-25A

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problem Aortic Insufficiency (1715)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020, a trifecta gt valve was selected for implant.On (b)(6) 2020 a valve in valve procedure was successfully performed with an evolut 26 valve due to aortic insufficiency caused by a suspected cusp tear.The patient was reported to be recovering.

• Brand Name: TRIFECTA GT VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); 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 (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10160670
• MDR Text Key: 195381316
• Report Number: 3008452825-2020-00276
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018236
• UDI-Public: 05415067018236
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2023
• Device Model Number: TFGT-25A
• Device Catalogue Number: TFGT-25A
• Device Lot Number: 6949422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2019
• 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): Hospitalization; Life Threatening; Other; Required Intervention