MAUDE Adverse Event Report: ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA) EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number E100-27M

Device Problem Torn Material (3024)

Patient Problems Cardiopulmonary Arrest (1765); Loss of consciousness (2418)

Event Date 11/06/2014

Event Type  Injury  

Event Description

A 27mm epic valve was implanted in the mitral position.At some point post-implant, a leaflet tear was suspected and the patient was admitted to undergo explant.The patient experienced cardiac arrest and the procedure was canceled.The patient remains unconscious and is undergoing dialysis.The physician said reoperation was questionable due to the patient¿s advanced age and the valve remains implanted.

Manufacturer Narrative

The results of the investigation are inconclusive since the valve remains implanted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 3400 0-00; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 3400 0-00; BR 34000-000
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4275286
• MDR Text Key: 18798122
• Report Number: 3001743903-2014-00056
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PP040021
• 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: 11/06/2014

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: Physician
• Device Expiration Date: 02/16/2015
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: 3384458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2014
• Initial Date FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2011
• 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): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 42