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 E100-29M

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Dyspnea (1816)

Event Date 07/02/2015

Event Type  Injury  

Event Description

This 29 mm sjm epic mitral valve was implanted on (b)(6) 2012.In (b)(6) 2015, after a flu episode, the patient presented with the onset of dyspnea with moderate exercise which resolved with rest.During an echocardiogram the bioprosthesis appeared thickened with leaflet failure, the lvef was normal (65%), mean gradient was 6mm hg with an area of 2.1cm2 and moderate (3+) mr was noted (2 jets, one central and one eccentric).During the hospitalization blood cultures were negative for endocarditis.The bioprosthesis was explanted and replaced with a 27 mm medtronic mosaic valve (s/n: (b)(4)).The patient was reported to be good post-operative.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Dyspnea, mitral regurgitation.Obstruction within device.The results of this investigation indicated there was a tear in cusp 1.There was focal fibrous pannus ingrowth on the inflow and outflow surfaces of cusp 2.There was a thin layer of fibrin on all cusps.Special stains were negative for organisms, and no acute inflammation or significant calcifications were present.There was no evidence found to suggest the cause of the fibrin, pannus, and tear 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. (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: 4943719
• MDR Text Key: 6256791
• Report Number: 3001883144-2015-00031
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2016
• Device Model Number: E100-29M
• Device Catalogue Number: E100-29M
• Device Lot Number: 3762853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2012
• 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: 78 YR
• Patient Weight: 68