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

Model Number	TFGT-29A
Medical Device Problem Codes	Backflow (1064); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Chest Pain (1776); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2019, a 29mm trifecta¿ gt valve was implanted.In (b)(6) 2021, the patient presented to the emergency room via ambulance due to sudden chest pain and was admitted to the hospital.An echocardiography was performed and aortic regurgitation (ar) was noted.A trans-esophageal echocardiogram (toe) was performed for further imaging and a possible tear was noted on the non-coronary cusp (ncc).On (b)(6) 2022, the valve was explanted and upon explant a 5mm parallel tear was noted on one of the leaflet stents.A new 27mm trifecta¿ gt valve was implanted.The patient was reported to be in stable condition.Operative notes and echo report was requested but cannot be obtained.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Additional Manufacturer Narrative
Explant was reported due to "aortic regurgitation" and "a possible tear was noted on the non-coronary cusp".The investigation found that all three leaflets were torn.Leaflet 1 and leaflet 3 had fibrous thickening.Leaflet 1 contained a fold.There was circumferential fibrous pannus ingrowth with narrowing of the inflow diameter.There was no acute inflammation or significant calcifications.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 demonstrate loss of collagen at two of the tear sites, which could have contributed to the formation of the tear.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 tears and fold causing incomplete coaptation could have contributed to the reported regurgitation.

• Brand Name: TRIFECTA¿ GT VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13440179
• Report Number: 3007113487-2022-00037
• Device Sequence Number: 17223653
• Product Code: LWR
• UDI-Device Identifier: 05415067018250
• UDI-Public: 05415067018250
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2020
• Device Model Number: TFGT-29A
• Device Catalogue Number: TFGT-29A
• Device Lot Number: 6996274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male