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

Model Number TFGT-21A

Device Problems Backflow (1064); Obstruction of Flow (2423); Material Split, Cut or Torn (4008)

Patient Problems Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported on (b)(6) 2021, that a 21 mm trifecta¿ gt valve was implanted in a patient with the comorbidities of obesity, dyslipidemia, and a past thyroidectomy.On an unknown date, the patient presented with acute aortic insufficiency due to grade 4 valvular regurgitation from valve deterioration.On (b)(6) 2021, the valve was explanted and replaced with a 19 mm non-abbott device to resolve the event.Upon explant, it was noted that there was a large tear from one stent post to another.The patient is recovering.No additional information was provided.

Manufacturer Narrative

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

Event Description

It was reported on (b)(6) 2021, that a 21 mm trifecta¿ gt valve was implanted in a patient with the comorbidities of obesity, dyslipidemia, and a past thyroidectomy.On an unknown date, the patient presented with acute aortic insufficiency due to grade 4 valvular regurgitation from valve deterioration.On (b)(6) 2021, the valve was explanted and replaced with a 19 mm non-abbott device to resolve the event.Upon explant, it was noted that there was a large tear from one stent post to another.The patient is recovering.No additional information was provided.

Manufacturer Narrative

Additional information: a2.Correction: b5, d6a, h6.

Event Description

It was reported that on (b)(6) 2018, a 21 mm trifecta¿ gt valve was successfully implanted in a patient with severe aortic stenosis.The patients comorbidities are obesity, dyslipidemia, and a past thyroidectomy.On an unknown date, the patient presented with cardiac decompensation, moderate stenosis, and acute aortic insufficiency due to grade 4 valvular regurgitation from valve deterioration.On (b)(6) 2021, the valve was explanted and replaced with a 19 mm non-abbott device to resolve the event.Upon explant, it was noted that there was a large tear from one stent post to another.The patient is recovering.No additional information was provided.

Manufacturer Narrative

An event of cardiac decompensation, stenosis, aortic insufficiency, valvular regurgitation, "a large tear from one stent post to another", and device explant 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
• 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: 13120171
• MDR Text Key: 285194713
• Report Number: 3014918977-2021-00130
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2019
• Device Model Number: TFGT-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 5845270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• 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): Required Intervention
• Patient Age: 74 YR