MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM EPIC SUPRA STENTED PORCINE HEART VALVE

Model Number ESP100-23

Device Problem Gradient Increase (1270)

Patient Problems Aortic Valve Stenosis (1717); Chest Pain (1776); Dyspnea (1816); Hematoma (1884); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 02/07/2014

Event Type  Injury  

Event Description

The information provided to sjm indicated a patient underwent aortic valve replacement with a 23mm sjm epic supra stent valve (mode: esp100-23, serial: (b)(4)) on (b)(6) 2013.While recovering, a pericardial effusion was noted and a pericardial drain was placed on (b)(6) 2013.A re-thoracotomy and a removal of a hematoma due to tamponade was performed.Three weeks prior to (b)(6) 2014, the patient complained of chest discomfort with dyspnea during exercise and a pre-syncopal episode on (b)(6) 2014.An echocardiogram revealed aortic stenosis and a high gradient.The valve was explanted and replaced with a 23mm sjm trifecta valve (model: tf-23a, serial: unk).The physician noted there was no calcification but there was vegetation on all three leaflets.

• Brand Name: SJM EPIC SUPRA STENTED PORCINE HEART VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL; belo horizonte ; BR
• Manufacturer Contact: denise johnson, rn ; rua professor jose vieira de mendonca, 1; bairro engenho nogueira; belo horizonte 31.31-0-26 ; BR 31.310-260
• MDR Report Key: 3682640
• MDR Text Key: 4293079
• Report Number: 3001883144-2014-00003
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2017
• Device Model Number: ESP100-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2013
• 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: 75 YR
• Patient Weight: 75