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

Catalog Number TF-21A

Device Problem Device Stenosis (4066)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 02/01/2023

Event Type  Injury  

Event Description

The article, "cor-knot use in savr facilitates coplanar angle adjustment during tavr", was reviewed.The article presented a case study of an 84-year-old female patient with chronic renal failure, with estimated glomerular filtration rate of 31 ml/min/m2.It was reported that on an unknown date in 2016, a 21mm trifecta valve was implanted.It was then reported on an unknown date post-procedure, the patient presented with severe aortic stenosis with a mean pressure gradient of 96mmhg.A decision was made to perform a transcatheter valve-in-valve procedure with a 23mm evolut pro plus valve.It was also reported preoperative computed tomography (ct) scan identified cor-knots in her aortic annulus.The patient was discharged to home the next day without renal injury.[the primary and corresponding author was (b)(6).].

Manufacturer Narrative

As reported in a research article, "cor-knot use in savr facilitates coplanar angle adjustment during tavr", on an unknown date in 2016, a 21mm trifecta valve was implanted in an 84-year-old female patient with chronic renal failure, with estimated glomerular filtration rate of 31 ml/min/m2.Post-procedural complications included surgical intervention, hospitalization, aortic stenosis and no peri-procedural complications were reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Literature attachment: cor-knot use in savr facilitates coplanar angle adjustment during tavr.

• Brand Name: SJM TRIFECTA 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: 18849822
• MDR Text Key: 337071922
• Report Number: 2135147-2024-01018
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: 05414734052023
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TF-21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 84 YR
• Patient Sex: Female