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

Model Number	TFGT-A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2017, a 27mm trifecta gt final package was implanted in a patient.The patient had dyspnea and compressive mid thoracic pain on exertion lasting less than 5 min (on exertion only).Must stop when walking.Amendment of symptoms at rest.There was a rupture of one of the leaflets of the aortic valve 5 years after implantation.On examination it appeared that the aortic valve was well inserted.There was a tear in the right coronary sigmoid along the stent.No sign of infection.On (b)(6) 2023, a complete removal of the 27mm trifecta gt took place, as well as an aortic valve replacement with a 27mm non-abbott device.The patient is stable.
Additional Manufacturer Narrative
An event of leaflet tear about 6 years after the valve was implanted and so the valve was explanted was reported.The investigation found that leaflets 2 and 3 were torn.There was a thin layer of pannus on the inflow surface of leaflet 2.No 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.In the absence of any calcification at the tear site 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 site.The cause of the leaflet tear could not be conclusively determined, however the pannus noted on the inflow surface 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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 17200369
• Report Number: 2135147-2023-02752
• Device Sequence Number: 20193878
• Product Code: LWR
• UDI-Device Identifier: 05415067018243
• UDI-Public: 05415067018243
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 11/17/2018
• Device Model Number: TFGT-A
• Device Catalogue Number: TFGT-27A
• Device Lot Number: 5761367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2016
• 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: Required Intervention
• Patient Sex: Unknown