MAUDE Adverse Event Report: ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA) EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number E100-25M

Device Problem Torn Material (3024)

Patient Problems Cardiac Arrest (1762); Mitral Regurgitation (1964)

Event Date 10/25/2014

Event Type  Injury  

Event Description

The patient underwent aortic valve replacement, mitral valve replacement and coronary artery bypass grafting (cabg) on (b)(6) 2012.An edwards magna ease (size unknown) was implanted in the aortic position and a 25mm sjm epic valve was implanted in the mitral position.No anomalies or issues were reported during the surgical procedure and perioperative period.Post discharge, the patient was followed-up at another facility where on (b)(6) 2013, mitral regurgitation grade 1 was noted.In (b)(6) 2014, at follow-up, mitral regurgitation grade 3 was noted.On (b)(6) 2014, mitral regurgitation grade 4 was noted and the patient had a cardiac arrest.On (b)(6) 2014, when the patient was in stable condition, a redo mitral valve replacement was performed.The 25mm sjm epic valve was explanted and a 27mm sjm epic valve was implanted.Upon explant, one cusp was noted to be horizontally torn from the anterior leaflet (a2) to the commissure position facing the aortic valve.The patient is recovering per report.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The results of this investigation concluded there was focal fibrous thickening of cusp 1 with incomplete coaptation, and a tear in cusp 3.Special stains revealed mixed gram positive rods and cocci.The clusters of mixed gram positive bacteria were seen predominantly on the surfaces of the cusps and without an inflammatory response.This likely represented a contaminant.No acute inflammation or significant calcifications were observed.There was no evidence found to suggest the cause of the fibrin, cuspal tear, and gram positive bacteria were due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the fibrin, cuspal tear, and gram positive bacteria remains unknown.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 3400 0-00; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 3400 0-00; BR 34000-000
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4291283
• MDR Text Key: 5085061
• Report Number: 3001743903-2014-00058
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PP040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

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: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: E100-25M
• Device Catalogue Number: E100-25M
• Device Lot Number: 3472244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2014
• Initial Date FDA Received: 12/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• 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: 78 YR