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

Model Number TFGT-21A

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

Patient Problem Aortic Regurgitation (1716)

Event Date 12/01/2020

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) 2018, a 21mm trifecta gt valve was implanted.In (b)(6) 2020, severe aortic regurgitation was observed and on (b)(6) 2020, the trifecta gt valve was explanted.Upon explant, a tear on the base from the rcc to the ncc was observed.A new 19mm trifecta gt valve was successfully implanted.The patient was reported to be in stable condition.

Manufacturer Narrative

Additional information sections: d9, h2, h3, h6, h10.Explant was reported due to regurgitation and upon explant a tear was noted.The investigation confirmed that a tear was present in leaflet 1 which extended into leaflet 2.Leaflets 2 and 3 contained calcifications.Stent posts 2 and 3 were bent outward.No acute inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.This was inclusive of a review of the manufacturing videos, which contained no evidence of anomalies or bent posts during functional inspection.Two outwardly bent stent posts were found.An outward bent stent post may result in a localized increase in leaflet stress which may potentially contribute to the leaflet tear, however it could not be conclusively determined whether the observed stent deformation occurred before or after valve explant making it difficult to determine the exact cause of the torn leaflets.The observed biological degeneration of the collagen at the tear site likely contributed to the observed torn leaflets.

• 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: 10971723
• MDR Text Key: 220395991
• Report Number: 3008452825-2020-00684
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• 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: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2021
• Device Model Number: TFGT-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 6242184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR