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

Model Number E100-27M

Device Problems Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problems Hemorrhage/Bleeding (1888); Pulmonary Edema (2020)

Event Date 12/13/2013

Event Type  Injury  

Event Description

The info provided to sjm indicated a 27mm epic valve was implanted on (b)(6) 2009.The pt presented with acute pulmonary edema and paravalvular leakage.The valve was explanted on (b)(6) 2013 when leaflet tear was found.A 27mm perimount magna ease was implanted.

• Brand Name: SJM EPIC STENTED PORCINE HEART VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL; belo horizonte ; BR
• Manufacturer Contact: denise johnson, rn ; 177 east county road b; st. paul, MN 55117 ; 6517564470
• MDR Report Key: 3565271
• MDR Text Key: 20660939
• Report Number: 3001743903-2014-00001
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2013
• Device Model Number: E100-27M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2013
• Date Device Manufactured: 11/12/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR