MAUDE Adverse Event Report: ST JUDE MEDICAL BRASIL LTDA SJM EPIC STENTED PORCINE HEART VALVE; STENTED TISSUE VALVE

Model Number E100-23A

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

Patient Problems Corneal Pannus (1447); Syncope (1610); Fatigue (1849); Stenosis (2263)

Event Date 03/27/2014

Event Type  Injury  

Event Description

The info provided to sjm indicated a 23mm epic valve was implanted on due to severe aortic stenosis and a radical prostatectomy was also performed.In the year following surgery, the pt was operated on for prostate cancer and received hormone therapy and radiation treatment.During the fall of 2013, the pt experienced syncope and fatigue.An echocardiogram revealed moderate leakage, thickened and calcified leaflets, severe stenosis and a gradient of 58 mmhg.Pannus was observed after explant.A 23mm trifecta (model: tf-23a, s/n: (b)(4)) was implanted and the pt was recovering following the event.

• Brand Name: SJM EPIC STENTED PORCINE HEART VALVE
• Type of Device: STENTED TISSUE VALVE
• Manufacturer (Section D): ST JUDE MEDICAL BRASIL LTDA; nova lima ; BR
• Manufacturer Contact: denise johnson, rn ; 177 e county rd b; st paul, MN 55117 ; 6517564470
• MDR Report Key: 3780678
• MDR Text Key: 4439984
• Report Number: 3001743903-2014-00023
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: EN
• 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: 03/27/2014

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: 06/13/2014
• Device Model Number: E100-23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/18/2014
• Date Device Manufactured: 06/14/2010
• 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: 66 YR