MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (CVD) SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-23A

Device Problems Backflow (1064); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problems Mitral Regurgitation (1964); Tricuspid Regurgitation (2112); Stenosis (2263); Low Cardiac Output (2501)

Event Date 11/20/2019

Event Type  Injury  

Event Description

On (b)(6) 2016, a 23mm trifecta valve was implanted due to bicuspid aortic stenosis.The patient has a history of mild liver disease and breast cancer.Three years post implant, the patient had breathlessness, peripheral oedema, and ascites with vomiting.The patient continued to deteriorate with hypotension and needed haemofiltration to support her renal function.Echocardiography revealed stenosis, mitral valve regurgitation, tricuspid regurgitation, increased gradient, and pulmonary hypertension.A valve-in-valve was performed on (b)(6) 2019 using a 26mm evolut r valve, with good hemodynamic results.The patient is currently recovering from renal and liver function, but shows good cardiac function.

Manufacturer Narrative

An event of breathlessness, peripheral edema, ascites with vomiting, stenosis, regurgitation, increase gradient, hypertension, and a valve-in-valve was reported.The results of the investigation are inconclusive since a valve-in-valve procedure was performed and the device was not accessible for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 9511540
• MDR Text Key: 173528664
• Report Number: 3008452825-2019-00657
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/19/2020

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?: No
• Device Operator: No Information
• Device Expiration Date: 04/17/2018
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 5494357
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/27/2019
• Supplement Dates FDA Received: 01/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR