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

Model Number ESP100-19

Device Problem Folded (2630)

Patient Problem Stenosis (2263)

Event Date 12/10/2013

Event Type  Injury  

Event Description

The information provided to sjm indicated a pt underwent aortic valve replacement on (b)(6) 2012, with a 19mm sjm epic supra stented valve (model: esp100-19, serial: (b)(4)).The pt presented with symptoms of stenosis and vegetation on the surface of the valve on (b)(6) 2013, with a peak gradient of 109mmhg and mean gradient of 56mmhg.The valve was explanted on (b)(6) 2013 and replaced with a non-sjm prosthesis.During the procedure it was noted that one of the leaflets was folded.The information provided suggests this or very similar events have occurred multiple times at this account.However, since specific information to initiate a complaint file was not available to facilitate separate investigations of these reported events, we have included them in this complaint file.

• Brand Name: SJM EPIC SUPRA STENTED PORCINE HEART VALVE
• Manufacturer (Section D): ST JUDE MEDICAL; belo horizonte ; BR
• Manufacturer Contact: denise johnson, rn ; caixa postal 106; belo horizonte ; BR ; 6517564470
• MDR Report Key: 3704805
• MDR Text Key: 4333677
• Report Number: 3001743903-2014-00002
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: Physician
• Type of Report: Initial
• Report Date: 12/10/2013

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: 11/30/2015
• Device Model Number: ESP100-19
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/13/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2013
• Initial Date FDA Received: 01/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2011
• 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: 38 YR