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

Catalog Number TFGT-23A

Device Problems Insufficient Information (3190); Device Stenosis (4066)

Patient Problems Angina (1710); Aortic Valve Stenosis (1717); Cardiac Arrest (1762); Insufficient Information (4580)

Event Date 02/24/2020

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant informationna.

Event Description

It was reported that on (b)(6) 2020, a 23mm trifecta gt valve was successfully implanted.About three years post-procedure, the patient underwent a replacement surgery due to the trifecta valve not functioning properly.However, the patient had passed away.No additional information was provided.

Manufacturer Narrative

An event of chest pain, severe aortic stenosis, cardiac arrest and patient death 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.It was indicated that the patient have severe stenosis and two of the three leaflets were torn.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Abbott also requested for image of the device/issue, patient's comorbidities and pre-existing medical conditions which were not provided by the field.However, based on the information received, the reported stenosis is consistent with structural valve deterioration (svd), specifically fibro-calcific svd (fcsvd), which is a well-known complication of tissue heart valve replacement surgery.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 stenosis such as calcification (from patient conditions predisposing to elevated calcium like renal disease etc.), immobilizing thrombus, or pannus formation reducing the valve diameter also could not be confirmed as the valve was not returned for histopathological examination.Based on received information, the cause of 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.From medical review: "the exact cause for the cardiac arrest is unknown but may be related to coronary obstruction which is a known potential complication during a valve-in-valve procedure.Pre-procedure planning may be used to identify a high risk anatomy for coronary anatomy and subsequently use various techniques to minimize risk.The cause of death is procedure related.Not device related."h6 health effect - clinical code: code 4580 removed h6 medical device problem code: 3190 removed.

Event Description

It was reported that on (b)(6) 2020, a 23mm trifecta gt valve was successfully implanted.On (b)(6) 2023, the patient was presented with chest pain and was diagnosed with severe aortic stenosis.On (b)(6) 2023, the patient underwent a valve-in-valve procedure using a 23mm non-abbott device.During the procedure, the patient went into cardiac arrest, requiring resuscitation.The patient was placed on extracorporeal membrane oxygenation (ecmo).The patient expired on (b)(6) 2023.

• Brand Name: TRIFECTA¿ GT VALVE
• Type of Device: 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: 18798989
• MDR Text Key: 336459061
• Report Number: 2135147-2024-00906
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: 05415067018229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2023
• Device Catalogue Number: TFGT-23A
• Device Lot Number: BR00019424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening; Other; Death
• Patient Age: 67 YR
• Patient Sex: Male