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

Model Number TF-29A

Device Problem Leak/Splash (1354)

Patient Problems Aortic Insufficiency (1715); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Date 06/08/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the patient underwent an aortic valve replacement secondary to a thickened and fibrotic bicuspid valve with partial fusion of both commissures due to fibrosis and calcification.Concomitant procedures consisted of coronary artery bypass grafting x3, and resection of an ascending aortic aneurysm with a 30mm dacron graft.This 29 mm sjm trifecta valve was implanted utilizing non-everting horizontal mattress sutures.After weaning the patient from cardiopulmonary bypass, the intraoperative transesophageal echocardiogram (tee) showed a single jet of aortic insufficiency near the non-coronary cusp.The aortic insufficiency appeared to be clearly within the prosthesis and not paravalvular.Bypass was reinstituted and the valve was inspected.There did not appear to be any impingement on the valve and the valve appeared normal on gross inspection.It could not be ruled out that the aortotomy suture line had interfered with function of the valve but no surgical revision was undertaken.The aorta was closed and the patient was removed from bypass.Again, the tee demonstrated the presence of aortic insufficiency.Bypass was re-instituted and the valve was removed and a 27 mm tissue valve from another manufacturer was implanted.Upon completion of the procedures, the patient required high doses of inotropes, vasopressors and multiple transfusions, as well as an intra-aortic balloon pump due to ischemia.The patient was reported to be recovering.

Manufacturer Narrative

Voluntary medwatch report number: mw5043579.(b)(4).The results of this investigation indicated the valve met sjm specifications as supported by the valve's device history record and the analysis performed.Hydrodynamic testing at the time of manufacturing and upon return to st.Jude medical indicated the valve functioned normally.This test ensures proper cuspal coaptation and hemodynamic performance.There was no evidence to suggest that there was an intrinsic defect in the valve.The cause of the reported event remains unknown.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4946609
• MDR Text Key: 6033189
• Report Number: 3008452825-2015-00055
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2016
• Device Model Number: TF-29A
• Device Catalogue Number: TF-29A
• Device Lot Number: 4690741
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2014
• 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: 71 YR