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

Catalog Number TFGT-25A

Device Problems Calcified (1077); Device Stenosis (4066)

Patient Problems Aortic Valve Stenosis (1717); Shock (2072)

Event Date 01/25/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on an unknown date a 25mm trifecta valve was implanted.On (b)(6) 2024, a 23mm navitor valve with a small flexnav delivery system was chosen for off-label valve in valve implantation into the trifecta valve in an emergency procedure.The trifecta valve was calcified with high aortic stenosis.The patient was in cardiogenic shock.The navitor was implanted successfully within the trifecta with a good result.No additional information was provided.There was no patient consequences.

Manufacturer Narrative

An event of valve being calcified with high aortic stenosis was reported.It was also reported that the patient was in cardiogenic shock.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.However, based on the information received, the reported stenosis is consistent with structural valve deterioration (svd).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 reported calcifications on valve could have contributed to the reported stenosis, however it could be confirmed as the valve was not received for examination.

Event Description

It was reported that on an unknown date in 2015, a 25mm trifecta valve was implanted.On (b)(6) 2024, a 23mm navitor valve with a small flexnav delivery system was chosen for off-label valve in valve implantation into the trifecta valve in an emergency procedure.The trifecta valve was calcified with high aortic stenosis.The patient was in cardiogenic shock.The navitor was implanted successfully within the trifecta with a good result.No additional information was provided.There was no patient consequences.

• 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 #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: 18733981
• MDR Text Key: 335808542
• Report Number: 2135147-2024-00732
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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 Catalogue Number: TFGT-25A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 64 YR
• Patient Sex: Male