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

Model Number E100-27M

Device Problem Material Deformation (2976)

Patient Problems Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)

Event Date 03/25/2019

Event Type  Injury  

Event Description

In 2013, a 27mm epic valve was implanted in the mitral position.On (b)(6) 2019, a mitral valve replacement was performed due to mitral stenosis and regurgitation.The device was explanted and exchanged for a 23mm carpentier-edwards perimount magna ease valve.The physician reported one of the three cusps of the explanted device was shortened due to possible stiffening resulting in the reported leakage.No calcification was observed on the valve.

Event Description

In 2013, a 27mm epic valve was implanted in the mitral position.On (b)(6) 2019, a mitral valve replacement was performed due to mitral stenosis and regurgitation.The device was explanted and exchanged for a 23mm carpentier-edwards perimount magna ease valve.The physician reported one of the three cusps of the explanted device was shortened due to possible stiffening resulting in the reported leakage.No calcification was observed on the valve.

Manufacturer Narrative

It was reported that the valve was explanted due to stenosis and regurgitation.The reported stiffened and "shortened" cusp was confirmed.Fibrous pannus ingrowth was present circumferentially on the outflow surface and the inflow surface of cusps 1 and 2.Cusps 2 and 3 were retracted and folded, and tethered by pannus.Microcalcifications were present on cusps 2 and 3.No acute inflammation was found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The noted tissue and resulting pinning effect on the cusps was consistent with the reported event.The root cause of the pannus could not be conclusively determined; however, information from the field indicated that the valve was replaced with a smaller, 23mm, valve, which may have been evidence of oversizing.

• 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.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 8533089
• MDR Text Key: 142541876
• Report Number: 3001883144-2019-00027
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2016
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: 3784813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention