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 Problem Leak/Splash (1354)

Patient Problem Mitral Regurgitation (1964)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2013, a mitral valve replacement (mvr) was performed and this 27mm epic valve was implanted utilizing everting mattress sutures.On (b)(6) 2016, an echocardiogram revealed grade iii/iv mitral regurgitation with an eccentric jet distorted toward the ventricular septal wall.On (b)(6) 2016, re-do mvr was performed and the epic valve was explanted.Upon explant, thinning was observed at the commissure of the posterior cusp with distortion of the cusp which was presumed to have resulted in the leakage.A 25mm tissue valve from another manufacturer was implanted.The patient was reported to be in stable condition postoperatively.

Manufacturer Narrative

The results of this investigation concluded cusp 2 was torn.There was microscopic fibrous pannus ingrowth on the inflow surface of cusp 1.No acute inflammation or significant calcifications were present in the valve.Gram stains were negative for organisms.Gms silver stains revealed fungal hyphae on cusps 1 and 2; there was no associated inflammation or fibrin thrombus formation.This appeared to be a contaminant.A review of the device history record showed the device met specifications prior to leaving sjm manufacturing facilities.There was no evidence found to suggest the cause of the tear and pannus 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 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 ; 6517564470
• MDR Report Key: 6158595
• MDR Text Key: 61898862
• Report Number: 3001883144-2016-00078
• 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,Followup
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2017
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: 4081612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2013
• 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: 74 YR