MAUDE Adverse Event Report: ABBOTT MEDICAL TRIFECTA¿ GT VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number	TFGT-21A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450); Pulmonary Hypertension (4460)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2020, a 21mm trifecta gt valve was implanted during an aortic valve replacement.The patient's native valve measurements were approximately 21mm in diameter.It was also reported that during a follow-up echocardiography on (b)(6) 2022, there were no issues reported.It was then reported on an unknown date, the patient presented with acute heart failure, pulmonary hypertension, severe aortic regurgitation, moderate mitral regurgitation, and moderate tricuspid regurgitation.On (b)(6) 2023, structural valve deterioration (svd) was confirmed via echocardiography showing a tear on the left coronary cusp and three commissures (stent posts) were attached to the aortic wall.A decision was made to perform an emergency surgical procedure to explant the valve and replace with a 21mm non-abbott valve.The patient status was stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Explant due to aortic regurgitation and torn cusp was reported.The investigation found that leaflet 2 was torn and folded.There was fibrous pannus ingrowth on the inflow surface with narrowing of inflow diameter.There was no inflammation or significant calcifications.The device history record was also 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.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 addition, the pannus noted could have increased stress on adjacent leaflets and created an unbalanced stress relief distribution between all leaflets during coaptation, which may lead to leaflet tears and reduced durability.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: TRIFECTA¿ GT VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17941174
• Report Number: 2135147-2023-04528
• Device Sequence Number: 17746529
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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: 10/15/2023
• Device Catalogue Number: TFGT-21A
• Device Lot Number: BR00022798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2019
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female