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

Catalog Number	TFGT-25A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Fatigue (1849); Heart Failure/Congestive Heart Failure (4446)
Date of Event	03/20/2024
Type of Reportable Event	Death
Event or Problem Description
User facility medwatch report mw5155723 received that states "my daughter received the st jude trifecta valve (b)(6) 2017.She did fine up until 8-10 months ago.She developed fatigue, shortness of breath, and edema.It took her 6 months get in to be seen by a cardiologist.When she finally did, she was in severe heart failure.She had an echo completed and her ejection fraction had reduced to 20% and her implanted aortic valve was severely stenotic.She was transferred to a higher level of care.She underwent open heart surgery (b)(6) 2024.She required echmo and a pump.Her chest was never able to be closed.She fought for 10 days and passed away (b)(6) 2024.(b)(6) hospital in (b)(6) should have pictures of the valve.I do not know if they kept of valve or sent it for pathology." it was reported that in 2017, a trifecta valve was implanted during an aortic valve replacement.In 2023, the patient developed fatigue, shortness of breath, and edema.Six months after symptoms began, the patient was seen by a cardiologist, and the patient was in severe heart failure.An echocardiogram was completed, and ejection fraction was 20%.The implanted valve was severely stenotic.The patient underwent open heart surgery in 2024.The patient was on extracorporeal membrane oxygenation (ecmo) and a pump.The patient's chest was not able to be closed.The patient died 10 days after the procedure.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attachment medwatch report# mw5155723.
Additional Manufacturer Narrative
An event of explant after seven years of implant due to severe heart failure, reduced ejection fraction, severe valve stenosis was reported.It was reported that the patient had developed fatigue, shortness of breath and edema in 2023, six month prior to be seen by cardiologist.The patient underwent open heart surgery in 2024 to explant and replace the valve with a non-abbott valve.Information from field indicated that the patient was on extracorporeal membrane oxygenation (ecmo) and a pump and the patient's chest was not able to be closed.Reportedly, the patient expired 10 days after the procedure.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device 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.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.
Event or Problem Description
User facility medwatch report mw5155723 received that states "my daughter received the st jude trifecta valve (b)(6) 2017.She did fine up until 8-10 months ago.She developed fatigue, shortness of breath, and edema.It took her 6 months get in to be seen by a cardiologist.When she finally did, she was in severe heart failure.She had an echo completed and her ejection fraction had reduced to 20% and her implanted aortic valve was severely stenotic.She was transferred to a higher level of care.She underwent open heart surgery (b)(6) 2024.She required echmo and a pump.Her chest was never able to be closed.She fought for 10 days and passed away (b)(6) 2024.(b)(6) hospital in (b)(6) should have pictures of the valve.I do not know if they kept of valve or sent it for pathology." it was reported that on 16 january 2017, a 25mm trifecta gt valve was implanted during an aortic valve replacement.In 2023, the patient developed fatigue, shortness of breath, and edema.Six months after symptoms began, the patient was seen by a cardiologist, and the patient was in severe heart failure.An echocardiogram was completed, and ejection fraction was 20%.The implanted valve was severely stenotic.The patient underwent open heart surgery in 2024 to explant and replace the valve with a non-abbott valve.The patient was on extracorporeal membrane oxygenation (ecmo) and a pump.The patient's chest was not able to be closed.The patient died 10 days after the procedure on (b)(6) 2024.

• 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: 19656243
• Report Number: 2135147-2024-03206
• Device Sequence Number: 6624443
• Product Code: LWR
• UDI-Device Identifier: 05415067018236
• UDI-Public: (01)05415067018236(17)181108(10)5748246
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 11/08/2018
• Device Catalogue Number: TFGT-25A
• Device Lot Number: 5748246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2016
• 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: Death
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White