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

Model Number TF-19A

Device Problems Calcified (1077); Gradient Increase (1270)

Patient Problems Syncope (1610); Calcium Deposits/Calcification (1758); Death (1802); Dyspnea (1816); Pulmonary Edema (2020); Valvular Stenosis (2697)

Event Date 03/17/2020

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2016, a (b)(6) years old patient with a history of dyspnea (nyha ii), dyslipidemia, and hypothyroidism had a surgical aortic valve replacement with a 19mm trifecta valve, and venous grafting.In (b)(6) 2019, the patient had a pulmonary edema and the echo showed high gradients and low ejection fraction.The patient was treated with medication and recovered.The patient subsequently had three more cases of pulmonary edema before a decision was made to explant the valve.On (b)(6) 2020 the patient presented syncope episodes with hemodynamic decline and diuretic interruption.On (b)(6) 2020, the trifecta valve was explanted.The device was founded to be stenotic and calcified.A sorin perceval small sutureless valve (small) was implanted.During the procedure, the patient developed cardiogenic shock.After 120 minutes of mechanical support, the heart shows no improvement in contractility.The patient terminated due to biventricular heart failure - asystole.

Manufacturer Narrative

The reported calcification caused stenosis was confirmed.All three leaflets were calcified and there was circumferential fibrous pannus ingrowth on the inflow and outflow surfaces, immobilizing the leaflets.All three leaflets contained tears associated with calcifications.No acute inflammation was found.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.The pannus and calcification caused leaflet immobility is consistent with the reported event.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• MDR Report Key: 9953563
• MDR Text Key: 187532859
• Report Number: 3008452825-2020-00196
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/08/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2017
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 5211369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 05/15/2020
• Supplement Dates FDA Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other; Required Intervention
• Patient Age: 78 YR