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

Model Number E100-29M

Device Problem Torn Material (3024)

Patient Problems Dyspnea (1816); Pneumonia (2011)

Event Date 02/27/2015

Event Type  Injury  

Event Description

On (b)(6) 2011, a maze procedure, tricuspid annuloplasty, and mitral valve replacement procedure was performed due to atrial fibrillation, moderate tricuspid regurgitation, and rheumatic mitral disease.This 29 mm sjm epic valve was implanted in the mitral position.The operation was uneventful with the patient in sinus rhythm and a stable cardiac state.An echocardiogram documenting good function of the bioprosthesis was performed in (b)(6) 2014.In (b)(6) 2015, the patient was hospitalized due to dyspnea and pneumonia.A torn cusp and regurgitation of the mitral bioprosthesis were seen on echocardiogram.On (b)(6) 2015, the mitral valve was explanted and replaced with another 29 mm sjm epic valve.The patient was reported to be recovering post procedure.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The results of this investigation concluded cusp 2 contained two tears, and cusp 3 was fibrotically thickened.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 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, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4636174
• MDR Text Key: 15234629
• Report Number: 3008452825-2015-00013
• 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: 02/27/2015

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: 12/06/2014
• Device Model Number: E100-29M
• Device Catalogue Number: E100-29M
• Device Lot Number: 3276315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2015
• Initial Date FDA Received: 03/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2010
• 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: 55 YR