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

Model Number E100-27M

Device Problem Torn Material (3024)

Patient Problems Death (1802); Mitral Regurgitation (1964); Multiple Organ Failure (3261)

Event Date 05/30/2017

Event Type  Death  

Event Description

On (b)(6) 2014, a double valve replacement (dvr) was performed and a 27 mm epic valve was implanted in the patient's mitral position, and a 19 mm epic valve (serial: (b)(4)) in the aortic position.On (b)(6) 2017, ascending aortic arch replacement was performed for the surgical treatment of an ascending aortic aneurysm.Subsequently, when the function of the epic valves implanted in both the mitral and aortic positions was checked, severe mitral regurgitation (mr) was confirmed.A re-do mitral valve replacement (mvr) was performed and the 27mm epic valve was explanted.Upon explant, a leaflet tear was observed.There is no information available about where the tear was located, but it was not reported to be at the commissure.A carpentier-edwards perimount magna ease mitral heart valve (size unknown) was implanted.The 19 mm epic valve remains implanted in the aortic position.Postoperatively, bleeding were reported which led to multiple organ failure.The cause of the bleeding remains unknown.On an unknown date, the patient reportedly died.The cause of death has not been disclosed.No further information is expected.

Manufacturer Narrative

The results of this investigation concluded cusp 1 contained a tear and there was thinning and loss of collagen fibers.There was focal calcification limited to the sewing cuff near cusp 2.No acute inflammation was present in the valve.There was no evidence found to suggest the cause of the tear or calcification was due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.

• 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. (PAMPULHA); 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. (PAMPULHA); 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: 6686115
• MDR Text Key: 79052526
• Report Number: 3001883144-2017-00040
• 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: 08/02/2017

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: 08/18/2017
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: 4444995
• Other Device ID Number: 05414734027526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2017
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 07/18/2017
• Supplement Dates FDA Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2013
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 82 YR