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

Model Number TFGT-25A

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

Patient Problems Cardiac Arrest (1762); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that on (b)(6) 2017, an aortic valve replacement(avr) and coronary artery bypass grafting(cabg) was performed in which a 25mm trifecta gt valve was implanted in a patient with aortic stenosis and coronary artery disease (cad).In dec.2020, the patient suffered acute heart failure and cardiac arrest and was brought to the emergency center.A coronary angiogram (cag) and detailed examination of the coronary arteries was performed, but no particular problem was noted.However, the cause was thought to be due to moderate/severe aortic regurgitation (ar) from the trifecta gt valve.It was decided to closely monitor the patient.During a follow-up on (b)(6) 2021, severe ar and cardiac dysfunction was observed, so it was decided to perform a aortic valve replacement (avr), mitral valve repair (mvp), and a tricuspid annuloplasty (tap) procedure.The trifecta gt valve was explanted, and replaced with a non-abbott device.The explanted device was noted to have a leaflet tear from left coronary cusp (lcc) and the right coronary cusp (rcc) commissure to the rcc side.According to the surgeon, his subordinate doctor had implanted the valve, and that the high aortic incision line made it difficult to ligate, which might have damaged the trifecta gt valve.The patient remained hemodynamically stable throughout the procedure and is currently stable.

Manufacturer Narrative

Additional information: d9, g3, h2, h3, h6, h10.Explant was reported due to regurgitation and leaflet tears were found at explant.Leaflet 1 and 3 were torn.There was mild degenerative changes to leaflet 3.There was surface basophilic foreign material consistent with surgical material on leaflet 3.No acute inflammation, significant calcifications, or stent post deformation were 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 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 demonstrate loss of collagen at a tear site, which could have contributed to the formation of the tear.

• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12253627
• MDR Text Key: 264322263
• Report Number: 3014918977-2021-00041
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018236
• UDI-Public: 05415067018236
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2018
• Device Model Number: TFGT-25A
• Device Catalogue Number: TFGT-25A
• Device Lot Number: 5746281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male