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 E100-25A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Corneal Pannus (1447)

Event Date 01/14/2015

Event Type  Injury  

Event Description

Post procedure, the patient became increasingly symptomatic and an echocardiogram showed the valve was incompetent.The tissue valve was explanted and pannus growth was noted on the valve leaflets.A 23 mm mechanical valve was implanted and the patient is recovering uneventfully.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The results of the investigation concluded all three cusps were fibrotically thickened and contained outflow thrombus.Focal calcifications were found within the thrombus on cusp 2, and a fold was observed in its mid-portion.Fibrous pannus ingrowth was also observed on the inflow surface of cusp 2.Gram stains were negative for organisms.No evidence was found to suggest the cause of the thrombus, calcification, pannus, and cuspal fold 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: 4555920
• MDR Text Key: 5528328
• Report Number: 3008452825-2015-00006
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2017
• Device Model Number: E100-25A
• Device Catalogue Number: E100-25A
• Device Lot Number: 4120386
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2013
• 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: 62 YR