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

Model Number EL-29M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Ischemia (1942); Myocardial Infarction (1969); Sepsis (2067); Heart Failure (2206)

Event Date 01/14/2015

Event Type  Injury  

Event Description

In (b)(6) 2005, the patient underwent a mitral valve replacement for rheumatic valve stenosis where this tissue valve was implanted, and a concomitant maze procedure with closure of the left atrial appendage.In 2008, the patient had a thromboembolic infarction of the right coronary artery treated with thrombectomy and coronary artery stenting.In 2010, the patient had an embolic ischemia of the left leg, which was surgically treated.In 2013, the patient was hospitalized with septicemia and per report had normal valve function.In (b)(6) 2015, the patient presented with cardiac failure.Aortic and mitral valve replacement and tricuspid annuloplasty was performed.A larger 31 mm bioprosthesis was implanted in the mitral position.The explanted mitral valve was noted to be heavily calcified with pannus and cuspal tears.The patient was discharged from the hospital post procedure.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The results of this investigation concluded all cusps contained tears, calcifications, and were fibrotically thickened.There was fibrous pannus ingrowth on the inflow surface of all cusps.Special stains were negative for organisms, and no inflammation was present.There was no evidence found to suggest the cause of the fibrin, calcification, 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
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 3400 0-00; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 3400 0-00; BR 34000-000
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4516317
• MDR Text Key: 5443264
• Report Number: 3001743903-2015-00010
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: EN
• PMA/PMN Number: P040021
• 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: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2008
• Device Model Number: EL-29M
• Device Catalogue Number: EL-29M
• Device Lot Number: 2976616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2005
• 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: 67 YR