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 Problems Microbial Contamination of Device (2303); Obstruction of Flow (2423)

Patient Problems Corneal Pannus (1447); Endocarditis (1834); Mitral Insufficiency (1963)

Event Type  Injury  

Manufacturer Narrative

Events of endocarditis and leaflet prolapse were reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The following information comes from the abstract of the "(b)(6) journal of cardiovascular surgery" 2018, vol.47, no.4, p.162-165.Title: emergency surgical treatment for fungal prosthetic valve endocarditis due to giant vegetation.On an unknown date in 2008, the patient was diagnosed with chronic heart failure (chf).On an unknown date in 2012, a mitral valve replacement (mvr), tricuspid annuloplasty (tap) and maze procedure were performed.This 31mm epic valve was implanted in the patient's mitral position and a 34mm edwards mc3 tricuspid annuloplasty ring in the tricuspid position.In the beginning of (b)(6) 2014, the patient experienced general fatigue and loss of appetite.Later, the patient presented at the hospital with a high fever of 39.0 degrees celsius.A chest radiography revealed cardiothoracic ratio (ctr) of 60 percent, bilateral pleural effusions and significant pulmonary congestion.Candida grablata was detected by blood culture.A transthoracic echocardiography (tte) was performed and large vegetations were attached to both anterior and posterior leaflets on multiple sites of the 31mm epic valve, which were floating and had a maximum diameter of 20 mm.The patient's cardiac function was normal at this time; however, mitral regurgitation (mr) was confirmed.Due to the high possibility of leaflet prolapse and prosthetic valve endocarditis (pve) due to fungal infection an emergency surgery was performed.Upon explant of the 31mm epic valve, large and multiple vegetations were adhered on the valve and the leaflets had become disrupted and mostly prolapsed.No abscess was observed on the patient's native mitral annulus.A 31mm carbomedics valve (sorin) was implanted within the mitral position.No anomalies were noted on the patient's native aortic valve.After explant, fibrin and inflammatory cells were reported to be infiltrated over this valve on pathology findings.The leaflets and wall structure of this valve were also damaged.The candida grablata was confirmed again by the postoperative blood culture and conclusively diagnosed as fungal pve.Postoperatively, antibiotic therapy started and amphotericin b liposome was administered.On the 35th operative day, infective endocarditis (ie) turned negative from the blood culture.On the 42nd operative day, antibiotic therapy was stopped.On the 50th operative day, the patient was discharged from the hospital on foot.Patient specific information of patient identifier and birthdate are not available for this case.

• 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.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7866518
• MDR Text Key: 119921178
• Report Number: 3001883144-2018-00079
• 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
• Report Date: 09/11/2018

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 Model Number: E100-31M
• Device Catalogue Number: E100-31M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Weight: 46