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

Model Number TFGT-21A

Device Problems Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Corneal Pannus (1447); Aortic Valve Stenosis (1717); Chest Pain (1776)

Event Date 08/21/2020

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 (b)(6) 2018, an abbott sizer was used and a 21 mm trifecta gt valve was implanted in the patient's aortic position due to degeneration of the valve, with non-everting mattress suture technique using pledgets.The patient presented to the hospital complaining of recent chest pain during exertion.Severe aortic stenosis was confirmed in the examination, and a re-do avr was performed on (b)(6) 2020.Upon explant, pannus formation was confirmed on the inside of the valve, which was impeding mobility of the valve.Pannus formation is also suspected to be on the outflow side of the valve.The patient was implanted with a perceval sutureless aortic valve(by livanova) and is in stable condition post-operatively.

Manufacturer Narrative

Additional information for: d10, g4, g7, h2, h3, h6, and h10.The reported pannus formation was confirmed.Histopathological examination found circumferential fibrous pannus ingrowth on the inflow surface, which narrowed the inflow diameter.No acute inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The pannus ingrowth, and resulting narrowing of the inflow diameter, is consistent with the reported stenosis.

• 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: 10554524
• MDR Text Key: 207562862
• Report Number: 3008452825-2020-00478
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Model Number: TFGT-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 6026815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 11/11/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 52