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

Model Number E100-29M

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Dyspnea (1816); Mitral Insufficiency (1963); Pulmonary Edema (2020)

Event Date 08/06/2014

Event Type  Injury  

Event Description

The information provided to sjm indicated the patient underwent a double valve replacement procedure on (b)(6) 2012.A 21 mm sjm trifecta¿ valve was implanted in the aortic position and this 29 mm sjm epic¿ stented tissue valve was implanted in the mitral position.Postoperative course was characterized by implant of an sjm accent pacemaker.On (b)(6) 2014, the patient presented to the hospital with dyspnea, was treated with diuretic therapy, and was discharged.The patient presented to the hospital again on (b)(6) 2014 with severe pulmonary edema and was hospitalized.Transesophageal echocardiography revealed aortic insufficiency due to improper coaptation of the left coronary cusp.This mitral valve also showed transvalvular mitral insufficiency.The patient underwent a re-do double valve replacement procedure on (b)(6) 2014.During the explant procedure, the cusp corresponding to the left coronary sinus of the aortic trifecta¿ valve (medwatch report# 3008452825-2014-00034) was found to be detached near the annulus.One cusp of this mitral epic¿ stented tissue valve was found to be prolapsed.A 27 mm bioprosthetic valve from another manufacturer was implanted in the mitral position and a 21 mm bioprosthetic valve from another manufacturer was implanted in the aortic position.The patient was reported to be stable postoperatively.

Manufacturer Narrative

(b)(4).The results of this investigation concluded a focal outflow thrombus on the base of cusp 3, fibrous pannus ingrowth on the inflow surface of cusp 1, a thin layer of fibrin on the inflow and outflow surfaces of all cusps, fibrin deposition within the bases of all cusps, and a tear on cusp 2.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 fibrin, thrombus, 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 fibrin, thrombus, pannus, and tear remains unknown.

• Brand Name: EPIC¿ STENTED TISSUE VALVE
• 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 3131 0-26; 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 3131 0-26; BR 31310-260
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4064948
• MDR Text Key: 4853128
• Report Number: 3001883144-2014-00018
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PP040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2016
• Device Model Number: E100-29M
• Device Catalogue Number: E100-29M
• Device Lot Number: 3824041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2012
• 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: 85