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

Catalog Number	TFGT-25A
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Pain (1994)
Date of Event	11/20/2023
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
User facility medwatch report mw5151357 received that states "i experienced a severe pain in the upper back that lasted all day.Other symptoms were a chronic dry cough and shortness of breath i went to the emergency care unit where i received an echocardiogram and was admitted to the hospital.I was told that my aortic replacement valve had badly deteriorated and that i needed it to be addressed promptly.The deteriorated valve was a st.Jude trifecta gt installed on (b)(6) 2017.As a result i had a medtronic valve inserted bytavr (transcatheter aortic valve replacement)." it was reported that on (b)(6) 2017, a 25mm trifecta gt valve was implanted during an aortic valve replacement.On a later date, the patient experienced severe upper back pain, chronic dry cough, and shortness of breath.The patient presented to the emergency department and received an echocardiogram, which revealed valve deterioration.The patient was admitted to the hospital.On (b)(6)2023, the patient received a transcatheter aortic valve implantation, or valve-in-valve surgery.The patient status was stable.
Additional Manufacturer Narrative
An event of valve deterioration discovered via echocardiogram was reported.Information from the field indicated that the patient presented with severe upper back pain, chronic dry cough, and shortness of breath and that the valve had been implanted for 6 years.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.A variety of factors may contribute to svd, including patient, biological, and implant related factors: no implant related factors could be confirmed from the information received from the field as information related to implant procedure was not provided.Biological factors which can result in tissue degeneration such as calcification (from patient conditions predisposing to elevated calcium like renal disease etc.) or thinning of the prosthetic leaflet tissue (predisposing to leaflet tears) also could not be confirmed as the valve was not returned for histopathological examination.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.
Event or Problem Description
User facility medwatch report mw5151357 received that states "i experienced a severe pain in the upper back that lasted all day.Other symptoms were a chronic dry cough and shortness of breath i went to the emergency care unit where i received an echocardiogram and was admitted to the hospital.I was told that my aortic replacement valve had badly deteriorated and that i needed it to be addressed promptly.The deteriorated valve was a st.Jude trifecta gt installed on (b)(6) 2017.As a result i had a medtronic valve inserted bytavr (transcatheter aortic valve replacement)." it was reported that on (b)(6) 2017, a 25mm trifecta gt valve was implanted during an aortic valve replacement.On a later date, the patient experienced severe upper back pain, chronic dry cough, and shortness of breath.The patient presented to the emergency department and received an echocardiogram, which revealed valve deterioration.The patient was admitted to the hospital.On (b)(6) 2023, the patient received a transcatheter aortic valve implantation, or valve-in-valve surgery.The patient status was stable.No additional information was provided.

• 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: 18961324
• Report Number: 2135147-2024-01322
• Device Sequence Number: 8051931
• Product Code: LWR
• UDI-Device Identifier: 05415067018236
• UDI-Public: (01)05415067018236(17)200917(10)BR00010734
• 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: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2024

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: 09/17/2020
• Device Catalogue Number: TFGT-25A
• Device Lot Number: BR00010734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2016
• 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; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male