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 Problems Leak/Splash (1354); Material Perforation (2205)

Patient Problem Mitral Regurgitation (1964)

Event Date 09/21/2018

Event Type  Injury  

Manufacturer Narrative

An event of regurgitation with suspected perforation of a cusp was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined. the valve had been implanted for longer than six years.

Event Description

On (b)(6) 2012, a mitral valve replacement (mvr) was performed and this 27mm epic valve was implanted.On (b)(6) 2018, re-do mvr was performed due to mitral regurgitation (mr) caused by a suspected perforation of a cusp.This valve was explanted and replaced with a 25mm medtronic mosaic tissue valve.Patient specific information of weight is not available for this complaint.

Event Description

On (b)(6) 2012, a mitral valve replacement (mvr) was performed and this 27mm epic valve was implanted.A concomitant avr and tap were performed with a mc 30mm implanted in the tricuspid annulus and 21mm magna ease implanted in the aortic position.On (b)(6) 2018, re-do mvr was performed due to mitral regurgitation (mr) caused by a suspected perforation of a cusp.This valve was explanted and replaced with a 25mm medtronic mosaic tissue valve.Upon explant, a leaflet tear was noted.The patient has been recovering without any complication after surgery.Patient specific information of weight is not available for this complaint.

• 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 34000 -000; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7942683
• MDR Text Key: 123043136
• Report Number: 3001743903-2018-00025
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

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: 10/25/2015
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: 3616372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/08/2018
• Supplement Dates Manufacturer Received: 11/12/2018
• Supplement Dates FDA Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 82 YR