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

Model Number E100-21A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Pannus (1447); Death (1802); Cardiogenic Shock (2262); Valvular Stenosis (2697)

Event Date 08/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

This 21 mm sjm epic valve was implanted on (b)(6) 2015.On (b)(6) 2015, stenosis and pannus was noted.At explant, one of the cusps was hardened and discoloration was noted.The valve was replaced with a 21 mm sjm masters series mechanical valve.It is reported the patient expired due to cardiogenic shock post-operatively.

Manufacturer Narrative

(b)(4).The results of this investigation concluded a tear in cusp 1, fibrous pannus ingrowth on the inflow surface of cusps 1 and 3, and fibrin thrombus on the outflow surface of cusps 2 and 3.There was no evidence of acute inflammation or significant calcifications, and gram stains were negative for organisms.No evidence was found to suggest the cause of the pannus, thrombus, and cusp tear 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
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5080861
• MDR Text Key: 25954914
• Report Number: 3001743903-2015-00034
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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
• Report Date: 08/22/2015

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: 09/03/2017
• Device Model Number: E100-21A
• Device Catalogue Number: E100-21A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2013
• 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: 71 YR
• Patient Weight: 90