MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) TRIFECTA¿ GT VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TFGT-23A

Device Problems Backflow (1064); Biocompatibility (2886)

Patient Problems Renal Failure (2041); Cusp Tear (2656); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/25/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported that on a 23mm trifecta gt valve was implanted in the patient's aortic, supra-annular position with the non-everting mattress suture technique using pledgets on (b)(6) 2018.An abbott sizer was used in the surgery.No regurgitation was confirmed on echocardiography in (b)(6) 2021.On (b)(6) 2021, aortic regurgitation(moderate) was confirmed during regular hospital visit.The patient had no subjective symptoms.Renal failure was confirmed at the same time and the patient was hospitalized.Two days after the hospital admission, subjective symptoms appeared on the patient, which led to reoperation on (b)(6) 2021.The trifecta gt valve was explanted, replaced with non abbott valve.Upon explant, the non-coronary cusp (ncc) was confirmed to have torn from the right-coronary cusp (rcc )and the ncc stent post.Sub valvular pannus formation was confirmed, also(please refer to the attached schema for other details.).No additional information was provided.

Event Description

It was reported that a 23mm trifecta gt valve was implanted in the patient's aortic, supra-annular position with the non-everting mattress suture technique using pledgets on (b)(6) 2018.An abbott sizer was used in the surgery.No regurgitation was confirmed on echocardiography in (b)(6) 2021.On (b)(6) 2021, aortic regurgitation(moderate) was confirmed during regular hospital visit.The patient had no subjective symptoms.Renal failure was confirmed at the same time and the patient was hospitalized.Two days after the hospital admission, subjective symptoms appeared on the patient, which led to reoperation on (b)(6) 2021.The trifecta gt valve was explanted, replaced with non abbott valve.The patient remained hemodynamically stable throughout the procedure.Upon explant, the non-coronary cusp (ncc) was confirmed to have torn from the right-coronary cusp (rcc )and the ncc stent post.Sub valvular pannus formation was confirmed.

Manufacturer Narrative

Explant was reported due to aortic regurgitation.The investigation found that leaflet 1 and leaflet 3 were torn.There was fibrous pannus ingrowth on the inflow surface of leaflet 2 and leaflet 3.There was no inflammation or significant calcifications.A schema was received from the field which contained four images that appeared to show a leaflet tear and white tissue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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 sites.Also, the fibrous pannus ingrowth noted 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.The cause of the tear could not be conclusively determined.

• Brand Name: TRIFECTA¿ GT VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12655476
• MDR Text Key: 277096393
• Report Number: 3007113487-2021-00053
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: 05415067018229
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

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: 06/14/2021
• Device Model Number: TFGT-23A
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 6052533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 12/28/2021
• Supplement Dates FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male