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

Model Number E100-27M

Device Problem Positioning Problem (3009)

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

Event Date 12/17/2014

Event Type  Injury  

Event Description

In (b)(6) 2012, the patient underwent a mitral valve replacement and aortic valve with ascending aortic artery replacement procedure.A 27 mm sjm epic valve was implanted in the mitral position and a 21 mm sjm trifecta valve was implanted in the aortic position.Post implant, the patient developed severe mitral valve insufficiency of the epic valve requiring explantation.During the explant procedure, pannus was observed on the valve impeding the cusps.A 25 mm tissue valve from another manufacturer was implanted as a replacement.The aortic valve remained implanted.The patient was reported to be in stable postoperatively.

Manufacturer Narrative

Gtin number: unknown since serial number was not provided.

Manufacturer Narrative

The results of this investigation concluded cusp 1 contained a tear and missing tissue in the free edge.There was fibrous pannus ingrowth on the outflow surface of cusp 1 and the inflow surfaces of all cusps, resulting in a narrowing of the inflow diameter and fusion of cusps 2 and 3.There was fibrous thickening of all cusps, and a thin layer of fibrin on all cusps with eosinophils on the outflow surfaces of cusps 2 and 3.Special stains were negative for organisms, and there was focal calcification in the free edge of cusp 1.A review of the device history record could not be completed, as the serial number was unavailable.There was no evidence found to suggest there was an intrinsic defect in the valve, as supported by the analysis performed, but 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. (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 ; 6517565400
• MDR Report Key: 4423706
• MDR Text Key: 5280356
• Report Number: 3001883144-2015-00004
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/17/2014

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: E100-27M
• Device Catalogue Number: E100-27M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2014
• Initial Date FDA Received: 01/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 76 YR