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

Catalog Number	TFGT-27A
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Anemia (1706); Bradycardia (1751); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Heart Failure/Congestive Heart Failure (4446)
Date of Event	06/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2017, a 27mm trifecta gt valve was successfully implanted.During early 2023, the patient experienced problems with a murmur, fatigue, anemia, and kidney function parameters.The patient measured his blood pressure (bp) at home with omron bp device, showing the diastolic bp to be frequently at 55 and pulse as 57.The valve transitioned from mild leakage on (b)(6) 2023 to moderate leakage on (b)(6) 2024.The moderate leakage.At one point, the left ventricular ejection fraction (lvef) was <35% measured by echocardiogram.The patient was admitted to the hospital on (b)(6) 2024, and underwent transcatheter aortic valve replacement (tavr) with a non-abbott valve on (b)(6) 2024.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of murmur, fatigue, anemia, kidney function parameters and moderate leakage after over 5 years of implant was reported.It was reported that patient underwent transcatheter aortic valve replacement with a non-abbott valve.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.Factors that may cause or contribute to valve deterioration include implant-related factors, biological factors, and patient-related factors, none of which could be confirmed in this case.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.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: 18915016
• Report Number: 2135147-2024-01139
• Device Sequence Number: 6760388
• Product Code: LWR
• UDI-Device Identifier: 05415067018243
• UDI-Public: (01)05415067018243(17)201211(10)BR00010922
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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: 12/11/2020
• Device Catalogue Number: TFGT-27A
• Device Lot Number: BR00010922
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2016
• 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; Other; Required Intervention; Life Threatening
• Patient Sex: Unknown