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

Model Number TFGT-23A

Device Problems Backflow (1064); Biocompatibility (2886); Material Split, Cut or Torn (4008)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 04/07/2021

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On an unknown date a 23mm trifecta¿ gt valve was implanted.Around (b)(6) 2021, the patient presented to the hospital with suspicion of endocarditis however, test results found no reaction.The patient was diagnosed with aortic regurgitation (ar).On (b)(6) 2021, the valve was explanted and replaced with a m-size perceval suture less aortic valve by livanova.Upon explant, there were tears noted on the right coronary cusp (rcc) and the non-coronary cusp (ncc) and pannus formation was confirmed.The patient was reported to be in stable condition.

Manufacturer Narrative

Additional information: d9, h3, h6, h10 explant was reported due to aortic regurgitation.The investigation found that leaflet 3 was torn.There was circumferential fibrous pannus ingrowth on the inflow surface which extended onto the bases of all three leaflets and fibrous pannus ingrowth on the outflow surface which extended onto the base of leaflet 1.Leaflet 2 and leaflet 3 had focal outflow thrombus.No acute inflammation or significant calcifications.In the absence of any calcification or evidence of infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation did not demonstrate loss of collagen at the tear site and the cause of the leaflet tear could not be conclusively determined; however, the pannus noted on the inflow and outflow surfaces had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.

• 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: 11684689
• MDR Text Key: 245987655
• Report Number: 3008452825-2021-00236
• 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: 05/28/2021

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 Model Number: TFGT-23A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 05/27/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention