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 E100-29M

Device Problem Torn Material (3024)

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

Event Date 05/01/2017

Event Type  Injury  

Event Description

On (b)(6) 2012, a mitral valve replacement (mvr) was performed and a 29 mm epic valve was implanted.In (b)(6) 2017, the patient was symptomatic with cardiac murmur.On an unknown date, at the time of regular follow-up, an echocardiogram revealed mitral stenosis and regurgitation.On (b)(6) 2017, a re-do mvr was performed and this mitral valve was explanted.Ex vivo, a leaflet tear was noted at the free edge, which was located close to the side of the ncc of the aortic valve.A carpentier-edwards perimount magna ease mitral heart valve (size unknown) was implanted.The patient has been in stable condition postoperatively.

Manufacturer Narrative

The results of this investigation concluded there were tears in cusps 1 and 2.There was a thin layer of fibrous pannus on the outflow surface of cusp.The outflow surface of cusps 1 and 3 contained a basophilic foreign material which is most consistent with surgical material.No acute inflammation or significant calcifications were observed in the valve.A review of the device history record showed the device met specifications prior to leaving abbott manufacturing facilities.There was no evidence found to suggest the cause of the pannus and tears were 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. (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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6666271
• MDR Text Key: 78361118
• Report Number: 3001743903-2017-00027
• 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: 07/26/2017

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: 10/27/2015
• Device Model Number: E100-29M
• Device Catalogue Number: E100-29M
• Device Lot Number: 3616373
• Other Device ID Number: 05414734027533
• 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: 06/07/2017
• Initial Date FDA Received: 06/26/2017
• Supplement Dates Manufacturer Received: 07/12/2017
• Supplement Dates FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2011
• 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: 71 YR