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 E100-31M

Device Problem Microbial Contamination of Device (2303)

Patient Problems Stroke/CVA (1770); Endocarditis (1834)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

An event of endocarditis was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2018, a mitral valve replacement and a tricuspid annuloplasty were performed.The 31mm epic valve was implanted in the mitral position and an unspecified annuloplasty ring in tricuspid position.On an unknown date, the patient developed cerebral infarction and was re-admitted to the hospital.An echocardiography was performed and prosthetic valve endocarditis was suspected due to mobile vegetation on left atrial wall.On (b)(6) 2018, the epic valve was explanted.A vegetation-like material was observed adhered to the sewing cuff, which was extended to the left atrial wall.The adhered vegetation was negative in the culture test.Pathological analysis was conducted at the hospital; however, no bacteria was found.The valve was discarded at the hospital and not made available for return.A 31mm carpentier-edwards perimount magna ease mitral heart valve was implanted as the replacement.Postoperatively, warfarin has being administered and international normalized ratio of prothrombin time (inr) is maintained at 2.0.The patient has a medical history of chronic atrial fibrillation and underwent left atrial appendage closure.The surgeon assumed that this incident was possibly caused by nonbacterial thrombotic endocarditis (nbte).The nbte is likely developed in patients with cancer; however cancer was not detected in this patient by the preoperative inspection.

• 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, costa rica 1897- 4050; 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, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7654052
• MDR Text Key: 112840244
• Report Number: 3008452825-2018-00185
• 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: Health Professional
• Type of Report: Initial
• Report Date: 07/01/2018

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: 03/20/2020
• Device Model Number: E100-31M
• Device Catalogue Number: E100-31M
• Device Lot Number: 5454155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 07/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2016
• 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