MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) EPIC SUPRA VALVE W/FLEXFIT; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number ESP100-25

Device Problem Insufficient Information (3190)

Patient Problems Syncope (1610); Thrombus (2101); Complaint, Ill-Defined (2331); Fibrosis (3167)

Event Date 05/21/2015

Event Type  Injury  

Event Description

This 25 mm sjm epic valve was implanted on (b)(6) 2014.Two weeks prior to explantation ((b)(6) 2015), the patient experienced syncope and a declining state of health which worsened quickly.An eoa of 0.3mm2 was noted on echo and surgical intervention was recommended.At the time of explant, visible fibrous tissue was noted on all three cusps.On (b)(6) 2015, the hospital pathology analysis noted the tissue on the leaflets was confirmed thrombus formation.The patient received a carbomedics mechanical heart valve as a replacement.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4) - syncope; thrombus; obstruction within device; torn material.The results of this investigation concluded the outflow surface all three cusps and the inflow surface of cusp 2 contained organizing fibrin thrombus.A small tear was also observed in cusp 1.There was no evidence of acute inflammation or areas of calcification and gram stains were negative for organisms.No evidence was found to suggest the cause of the organizing fibrin thrombus formation 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 SUPRA VALVE W/FLEXFIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 3131 0-26; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 3131 0-26; BR 31310-260
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4851456
• MDR Text Key: 5811538
• Report Number: 3001883144-2015-00024
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: ESP100-25
• Device Catalogue Number: ESP100-25
• Device Lot Number: 4858583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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: 68 YR