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

Catalog Number TF-21A

Device Problems Patient-Device Incompatibility (2682); Material Split, Cut or Torn (4008)

Patient Problems Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 02/23/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The article, "unusual cause of severe transvalvular eccentric jet ar: early structure valve deterioration of trifecta valves by flail leaflet undergoing valve-in-valve transcatheter aortic valve replacement", was reviewed.The article presented a case study of a female patient in her 70s with dyspnea, hypertension, dyslipidemia, and an ascending aortic aneurysm and underwent an ascending aortic replacement with a dacron graft.It was reported that on an unknown date, a 21mm trifecta valve was implanted.It was then reported 7 years post-procedure, the patient presented with progressive dyspnea, chronic severe aortic regurgitation, and severe transvalvular aortic regurgitation was noted via transthoracic echocardiogram (tte).Cardiac computed tomography (ct) revealed a flail non-coronary cusp of the trifecta valve and presence of a small pannus that was thin and circumferential at the ventricular site of the aortic valve.A decision was made to perform a transcatheter valve-in-valve procedure with a 23mm evolut valve.The patient was discharged two days after and her symptoms of heart failure resolved.[the primary author was thirath chatlaong, division of cardiovascular medicine, department of medicine, king chulalongkorn memorial hospital, bangkok, thailand.The corresponding author was thitima limjareon, cardiac center, king chulalongkorn memorial hospital, bangkok, thailand, with corresponding email: (b)(6)].

Manufacturer Narrative

As reported in a research article,unusual cause of severe transvalvular eccentric jet ar: early structure valve deterioration of trifecta valves by flail leaflet undergoing valve-in-valve transcatheter aortic valve replacement.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: article title " unusual cause of severe transvalvular eccentric jet ar: early structure valve deterioration of trifecta valves by flail leaflet undergoing valve-in-valve transcatheter aortic valve replacement".

• 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: 18944674
• MDR Text Key: 338186372
• Report Number: 2135147-2024-01259
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 04/02/2024
• 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