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 03/19/2024

Event Type  Injury  

Manufacturer Narrative

Literature article attached: "enhancing transcatheter aortic valve implantation (tavi) outcomes through virtual proctoring: a case series analysis", investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, "enhancing transcatheter aortic valve implantation (tavi) outcomes through virtual proctoring: a case series analysis", was reviewed.The article presented a case study of an 82-year-old female patient.It was reported that on an unknown date, a 21mm trifecta valve was implanted.It was then reported on an unknown date, the patient presented with severe aortic valve stenosis and a decision was made to perform a transcatheter valve-in-valve procedure with concomitant coronary protection.[the primary and corresponding author was claudiu ungureanu, department of cardiology, jolimont hospital, la louvière, belgium, with corresponding email: claudiu.Ungureanu@jolimont.Be].

Manufacturer Narrative

As reported in a research article, enhancing transcatheter aortic valve implantation (tavi) outcomes through virtual proctoring: a case series analysis.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: enhancing transcatheter aortic valve implantation (tavi) outcomes through virtual proctoring: a case series analysis.

• 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: 19099814
• MDR Text Key: 340104583
• Report Number: 2135147-2024-01677
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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: TF-21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/02/2024
• 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
• Patient Age: 82 YR
• Patient Sex: Female