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

Catalog Number	TFGT-27A
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Anemia (1706); Aortic Valve Stenosis (1717); Fatigue (1849); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)
Date of Event	02/11/2020
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) 2020, a 27mm trifecta gt valve was successfully implanted in an aortic valve replacement.In 2024, the patient became very sick due to the valve, and the patient was hospitalized.
Event or Problem Description
It was reported that on (b)(6) 2020, a 27mm trifecta gt valve was successfully implanted in an aortic valve replacement.In (b)(6) 2024, the patient began experiencing symptoms of weakness and fatigue.In (b)(6) 2024, the patient went to the emergency department due to symptoms and appearance of paleness.The patient was admitted to the hospital with a low hemoglobin level of 7.2.A series of tests were performed, and no underlying cause was reportedly identified.Four days later, the patient was discharged with follow up appointments scheduled with a hemotologist/oncologist, during which the patient received multiple iron infusions.On (b)(6) 2024, the patient had a heart catheterization, which revealed aortic valve regurgitation.The patient also developed aortic stenosis.The patient was told that a transcatheter aortic valve implantation was necessary, and the procedure was scheduled for (b)(6) 2024.The patient was reported as stable.No additional information was provided.
Additional Manufacturer Narrative
H6 - adverse event problem: health effect - clinical code: removed code 4580 insufficient information.H6 - adverse event problem: medical device problem code: removed code 3190 insufficient information.An event of fatigue, anemia, aortic valve regurgitation and stenosis, surgical intervention, and unexpected medical intervention 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.The cause of reported patient effects fatigue and anemia could not be conclusively determined.The exact cause of the reported stenosis and regurgitation could not be conclusively determined.The reported unexpected medical intervention was a result of case-specific circumstances as the patient was admitted and iron transfusion was given.The reported surgical intervention was a result of case-specific circumstances as another procedure was performed.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 LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20105490
• Report Number: 2135147-2024-04297
• Device Sequence Number: 12872265
• Product Code: LWR
• UDI-Device Identifier: 05415067018243
• UDI-Public: (01)05415067018243(17)221103(10)BR00018699
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: 11/03/2022
• Device Catalogue Number: TFGT-27A
• Device Lot Number: BR00018699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2018
• 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
• Patient Age: 78 YR
• Patient Sex: Male