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

Model Number E100-31M

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Dyspnea (1816); Tricuspid Regurgitation (2112)

Event Date 11/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2012, a tricuspid valve replacement (tvr) and surgical removal of the tumor on right atrium were performed.This 31 mm sjm epic valve was implanted in the tricuspid position utilizing the everting mattress suture technique with pledgets on the inflow side.Recently, the patient became symptomatic with chief complaint of shortness of breath and an echo revealed tricuspid regurgitation.On (b)(6) 2015, the valve was explanted from the tricuspid position and replaced with a 27 mm carpentier-edwards perimount magna mitral valve.Upon explant, no anomalies of the explanted epic valve were observed.The patient had no infection or antibiotic therapy.

Manufacturer Narrative

(b)(4).The results of this investigation concluded all three cusps were fibrotically thickened, and contained fibrous pannus ingrowth on their inflow and outflow surfaces.All three cusps were retracted, and cusps 2 and 3 contained focal calcifications.Cusp 3 contained two tears.There was no acute inflammation and gram stains were negative for organisms.No evidence was found to suggest the cause of the fibrous thickening, pannus, calcifications, cusp retractions and cusp tears was 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.; caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA.; caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 5306248
• MDR Text Key: 33751547
• Report Number: 3001743903-2015-00050
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

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: 04/27/2015
• Device Model Number: E100-31M
• Device Catalogue Number: E100-31M
• Device Lot Number: 3440996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2011
• 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: 72 YR