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); Material Integrity Problem (2978)

Patient Problems Aortic Regurgitation (1716); Discomfort (2330)

Event Date 04/30/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A 21 mm trifecta gt valve was implanted on (b)(6) 2018.The patient started to feel discomfort since (b)(6) 2020 and felt heart palpitation on (b)(6) so visited the hospital.Acute aortic regurgitation (ar) was diagnosed therefore an avr was conducted.The trifecta was explanted and 19 mm competitor's valve was implanted.A leaflet tear was observed near the stent post and extended along the stent post and pannus was observed on subvalvar tissue and outflow surface.The patient was reported to be in stable condition.

Manufacturer Narrative

The valve was reportedly explanted due to aortic regurgitation.The tear was confirmed.Leaflets 2 and 3 (rcc and lcc) were torn from their shared stent post.A small, detached, piece of fibrin thrombus was noted at leaflet 3, which was not considered diagnostically significant.No inflammation or significant calcifications were found.X-ray examination of the stent did not show evidence of deformation, which is consistent with proper handling of the valve at the time of valve insertion.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.In the absence of any calcification or evidence for 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, that the selected valve size (21 mm) was larger than the replacement valve (19 mm) is possible evidence of oversizing.

• 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: 10091445
• MDR Text Key: 192151821
• Report Number: 3008452825-2020-00226
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2021
• Device Model Number: TFGT-21A
• Device Lot Number: 6020224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 81 YR