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

Catalog Number	TFGT-23A
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Anemia (1706); Dyspnea (1816); Fatigue (1849); Hemorrhage/Blood Loss/Bleeding (1888); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	10/20/2022
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) 2018, a 23mm trifecta gt valve was implanted during an aortic valve replacement.On (b)(6) 2022, the valve was explanted due to unknown failure.The patient status was stable.
Additional Manufacturer Narrative
An event of shortness of breath, difficulty urinating, extreme fatigue, and defective device was reported.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 available information, the cause of the reported events could not be conclusively determined.The reported hospitalization and surgical intervention were influenced by case-specific circumstances, as the device was explanted and replaced with a new valve.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2018, a 23mm trifecta gt valve was implanted during an aortic valve replacement.In august 2022, an ultrasound of the patient's heart did not reveal any issues.In (b)(6) 2022, the patient experienced shortness of breath, difficulty urinating, and extreme fatigue.The patient was admitted to the hospital.The patient reported that their lungs had fluid buildup and that their ankles were swollen.During hospitalization, the patient's lungs were drained.The patient was sent home with a catheter and referred to a nephrologist for further assessment.On (b)(6) 2022, the patient experienced extreme shortness of breath and appeared "grey." the patient felt weak and fatigued.The patient was admitted to the hospital, and it was reported that the patient was in and out of consciousness.The patient was told that there was blood coming out of her nose and mouth, and the family was advised that it was the aortic heart valve.The patient additionally states that there was internal bleeding, which was resolved.On (b)(6) 2022, the patient underwent a transcatheter aortic valve implantation without complications.A 26mm non-abbott valve was implanted, and it was reported that the trifecta valve was explanted.The patient reported that they were on life support post procedure and had a low blood count.Patient was weak and required an extended hospital stay.The patient reports having to learn to talk and walk again.The patient reports that the physician sent the valve out for testing and that the results indicated that it was defective, but no other details were provided.The patient status was stable.

• 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: 20215577
• Report Number: 2135147-2024-04519
• Device Sequence Number: 7202181
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: (01)05415067018229(17)211119(10)BR00014841
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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: 11/19/2021
• Device Catalogue Number: TFGT-23A
• Device Lot Number: BR00014841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2017
• 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: 61 YR
• Patient Sex: Female