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

Model Number E100-27M

Device Problems Perivalvular Leak (1457); Torn Material (3024)

Patient Problems Corneal Pannus (1447); Aortic Insufficiency (1715); Aortic Valve Stenosis (1717)

Event Date 01/11/2018

Event Type  Injury  

Event Description

On (b)(6) 2012, a 27 mm epic valve was implanted in the mitral position.On (b)(6) 2018, the patient presented to the hospital in cardiac failure.An echocardiogram revealed mitral stenosis with regurgitation.The valve was explanted and a 23 mm carpentier-edwards perimount magna ease mitral heart valve was implanted as a replacement.The explanted valve had a tear at posterior leaflet from p1 to p2.A perforation on the anterior leaflet at the position of p2 to p3.Pannus and thrombus formation were noted on a portion of the anterior leaflet.The surgeon assumed the structural valve deterioration was secondary to infective endocarditis.The patient was reported to be on dialysis which may have accelerated the structural valve deterioration.Damage at the time of explant included device fractured on the cusps, sewing cuff, and stent.The patient has been in stable condition postoperatively.

Manufacturer Narrative

Product evaluation: an event of mitral stenosis and regurgitation was reported.Gross morphological and histopathological examination revealed all three cusps contained calcifications and tears.Fibrous pannus ingrowth on the inflow surface was noted on cusp 1.No acute inflammation was present in the valve.A review of the device history record showed the device met specifications prior to leaving abbott manufacturing facilities.The cause for 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.; 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7256501
• MDR Text Key: 99580532
• Report Number: 3001883144-2018-00021
• 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,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: 3677114
• Other Device ID Number: 05414734027526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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: 80 YR
• Patient Weight: 55