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

Catalog Number TF-23A

Device Problems Calcified (1077); Patient-Device Incompatibility (2682); Material Split, Cut or Torn (4008); Device Stenosis (4066); Central Regurgitation (4068)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/01/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article title "early structural valve deterioration of trifecta aortic bioprosthesis : report of a case".

Event Description

The article, "early structural valve deterioration of trifecta aortic bioprosthesis : report of a case", was reviewed.The article presented a case study of a 60-year-old male patient who underwent aortic valve replacement.It was reported that on an unknown date, a 23mm trifecta valve was implanted.Seven years post-procedure on an unknown date, the patient presented with progressive dyspnea, severe aortic regurgitation, and aortic stenosis.It was noted intraoperatively there was a large laceration in the left coronary cusp adjacent to the non-coronary and left coronary commissure and leaflet calcification.Further investigation noted circumferential fibrous pannus ingrowth at the inflow portion.A decision was made to explant the trifecta valve and replaced with an inspiris valve of unknown size.The patient additionally underwent concomitant mitral valve plasty and left atrial appendage clipping.The patient was reported stable and transferred to a rehabilitation facility on the 36th postoperative day.[the primary author was keita tanaka, japanese red cross medical center, tokyo, japan.].

Manufacturer Narrative

Summarized patient outcomes/complications of trifecta valve were reported in a research article in a subject population with unknown co-morbidities.Some of the complications reported were surgical intervention, hospitalization, dyspnea, aortic valve regurgitation, aortic valve stenosis, torn cusp, calcified device and pannus.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for 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: 18405967
• MDR Text Key: 331474258
• Report Number: 2135147-2023-05733
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

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-23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/10/2024
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 53 KG