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

Model Number TFGT-23A

Device Problems Backflow (1064); Incomplete Coaptation (2507)

Patient Problems Congestive Heart Failure (1783); Dyspnea (1816); Regurgitation (2259)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2018, the initial implant surgery was performed and a 23mm trifecta gt valve was implanted in the patient's aortic position.A trifecta sizer (model#: tf2000) was used in the surgery.Although a 25mm trifecta sizer passed through the patient's annulus, the 23mm trifecta gt valve was implanted with continuous suture technique, and so there was no contact with the leaflets during the implant.The patient presented to the hospital complaining of breathing difficulty in (b)(6) 2019.Mild regurgitation was confirmed in the echocardiogram.In (b)(6) 2020, the heart failure symptom worsened and the patient was hospitalized in emergency.The patient temporarily recovered with medication.A semi-emergency re-do avr was performed on (b)(6) 2020 and the trifecta gt valve was explanted, replaced with a 23mm carpentier-edwards perimount(cep) valve (manufacturer: edwards lifesciences).Upon explant, no tear was observed on the stent posts, but the ncc leaflet was confirmed to have prolapsed and appeared to have stretched, which was causing regurgitation from the center of the valve.The patient is stable.

Manufacturer Narrative

An event of leaflet prolapse and regurgitation was reported.Leaflets 1 and 2 contained tears at their shared stent post, consistent with the stated explant damage reported from the field.Leaflet 1 was fibrotically thickened.Pannus ingrowth was noted on the outflow surface covering stent post.There was partially detached pannus on the sewing cuff.When aligned against the shape of the tissue valve, the pannus was noted to conform to the inner stent wall, with some contact with the base of leaflet 1; however, the orientation of the pannus prior to explant could not be conclusively determined.Qualitative x-ray examination found no evidence of stent damage or deformation.No inflammation or significant calcifications were present.The device history record was reviewed to ensure each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.This was inclusive of a review of the manufacturing videos, which contained no evidence of anomalies during functional inspection.The final shape and height of each leaflet, while allowing for variation between, is the outcome of a rigorous manufacturing process that ensures consistent, optimal functional performance for each trifecta gt valve and proper coaptation at the free edge with no leaflet prolapse.The cause of the reported leaflet prolapse and regurgitation could not be conclusively determined.While it could not be definitively determined that the inflow pannus formation attached itself to the leaflet tissue while implanted, it, along with the outflow pannus covering stent post 1, had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation contributing to leaflet prolapse and loss of coaptation.

• 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
• MDR Report Key: 10714684
• MDR Text Key: 212397208
• Report Number: 3008452825-2020-00507
• Device Sequence Number: 1
• Product Code: LWR
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2021
• Device Model Number: TFGT-23A
• Device Lot Number: 6145196
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR