MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA. SJM EPIC SUPRA STENTED PORCINE HEART VALVE; STENTED TISSUE VALVE

Model Number ESP100-21-00

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombus (2101)

Event Date 03/15/2014

Event Type  Injury  

Event Description

The information provided to sjm indicated the valve was explanted since it had thrombosed.The patient was reported to be stable postoperatively.

• Brand Name: SJM EPIC SUPRA STENTED PORCINE HEART VALVE
• Type of Device: STENTED TISSUE VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA.; el coyol ; CS
• Manufacturer Contact: denise johnson, rn ; 177 east county road b; st. paul, MN 55117 ; 6517564470
• MDR Report Key: 3738571
• MDR Text Key: 4311348
• Report Number: 3008452825-2014-00007
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2016
• Device Model Number: ESP100-21-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2014
• Date Device Manufactured: 04/16/2012
• 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: 63 YR
• Patient Weight: 75