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

Model Number E100-27M-00

Device Problems Hole In Material (1293); Torn Material (3024)

Patient Problems Congestive Heart Failure (1783); Mitral Regurgitation (1964)

Event Date 01/03/2014

Event Type  Injury  

Event Description

The information provided to sjm indicated postoperatively, mitral regurgitation was noted with congestive heart failure.The valve was explanted and during the procedure, a tear was observed in one cusp and a hole observed in another cusp.The patient was reported to be in satisfactory condition following the explant procedure.

• Brand Name: SJM EPIC STENTED PORCINE HEART VALVE
• Type of Device: STENTED TISSUE VALVE
• Manufacturer (Section D): ST JUDE MEDICAL BRASIL LTDA; belo horizone
• Manufacturer Contact: denise johnson, rn ; 177 e county rd b; st paul, MN 55117 ; 6517564470
• MDR Report Key: 3628796
• MDR Text Key: 4203903
• Report Number: 3001743903-2014-00008
• Device Sequence Number: 1
• Product Code: LWQ
• 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: Unknown
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2012
• Device Model Number: E100-27M-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2014
• Date Device Manufactured: 10/21/2008
• 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: 68 YR
• Patient Weight: 82