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

Model Number E100-29M

Device Problem Torn Material (3024)

Patient Problem Mitral Regurgitation (1964)

Event Date 05/18/2018

Event Type  Injury  

Event Description

On (b)(6) 2013, a mitral valve replacement was performed and a 29mm epic valve was implanted.On (b)(6) 2018, the patient presented to the emergency room with mitral regurgitation.On (b)(6) 2018, the valve was explanted.Upon explant, the leaflet was noted to be detached from the stent base with a tear extending toward the next stent post positioned at the middle of the posterior leaflet.Neither pannus formation nor calcification were observed.A 29mm mosaic tissue valve (medtronic) was implanted as the replacement.The procedure was successfully completed with no further issues.Per report the patient has a medical history of hypertension and hyperlipidemia.

Manufacturer Narrative

An event of regurgitation was reported.The reported torn cusp was confirmed.Gross morphological and histopathological examination concluded one cusp was torn at its base.All three cusps were markedly thinned and cusp 3 contained outflow thrombus.No acute inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The root cause of the tear, thinning and thrombus remains unknown; however, information from the field indicated the patient had a history of hypertension and hyperlipidemia.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7615979
• MDR Text Key: 111607662
• Report Number: 3001883144-2018-00050
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2016
• Device Model Number: E100-29M
• Device Catalogue Number: E100-29M
• Device Lot Number: 3807936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2012
• 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: 87 YR