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

Model Number	TFGT-A
Medical Device Problem Codes	Incomplete Coaptation (2507); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on an unknown day in 2018, a 19mm trifecta gt valve was successfully implanted in a patient after having been sized using an abbott sizer set.On (b)(6) 2022, the patient returned due to an unknown reason.The patient underwent a valve-in-valve procedure with a non-abbott device being placed inside the 19mm trifecta gt valve.The patient was stable at the time of report.
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 an unknown day in 2018, a 19mm trifecta gt valve was successfully implanted in a patient after having been sized using an abbott sizer set.On (b)(6) 2022, the patient returned due to an unknown reason.The patient underwent a valve-in-valve procedure with a non-abbott device being placed inside the 19mm trifecta gt valve.The patient was stable at the time of report.Subsequent to the previously filed report, additional information was received that the 19mm trifecta gt valve had been implanted on (b)(6) 2018 in a patient with a two-cusped aortic valve.It was noted that the stent of the trifecta gt valve became deformed after being implanted in the patients two-cusped annulus.The patient also had a balloon aortic valvuloplasty performed and an ascending aortic replacement conducted that same day.On 05 july 2022, it was noted that there was incomplete coaptation of trifecta gt valve.It was noted during the valve-in-valve procedure that there was a tear on a leaflet of the 19mm trifecta gt valve.
Additional Manufacturer Narrative
An event of a leaflet tear and valve-in-valve was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Information from the field indicated that the issue thought to be caused by valve stent deformation during implant as the patient had a bicuspid valve, which then increased stress during leaflet coaptation, causing the leaflet tear.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: 15126169
• Report Number: 2135147-2022-00593
• Device Sequence Number: 12137362
• Product Code: LWR
• UDI-Device Identifier: 05415067018205
• UDI-Public: 05415067018205
• 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: 2018
• 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): 10/17/2022

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: 09/17/2021
• Device Model Number: TFGT-A
• Device Catalogue Number: TFGT-19A
• Device Lot Number: 6159758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 10/16/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2017
• 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; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Unknown