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 Torn Material (3024)

Patient Problem Mitral Regurgitation (1964)

Event Type  Injury  

Event Description

On (b)(6) 2013, a mitral valve replacement (mvr) was performed and this 27 mm epic valve was implanted.At the end of 2017, the patient developed dyspnea and severe mitral regurgitation (mr) was diagnosed.When an echocardiography and a computed tomography (ct) were performed, one of the leaflets of this valve was suspected to be torn.On (b)(6) 2018, a re-do mvr was performed and this valve was explanted and replaced with a 25 mm carpentier-edwards perimount magna ease mitral heart valve.

Manufacturer Narrative

The reported event of a torn leaflet was confirmed.Dyspnea and mitral regurgitation was also reported.Gross morphological and histopathological examination found cusps 1 and 3 were torn and cusp 2 had been previously excised.Fibrous pannus ingrowth was present on the outflow surface of cusp 1, which led to retractions in the cusp.No acute inflammation or significant calcifications were found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown; however, dyspnea and regurgitation are consistent with torn and retracted leaflets.

• 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 31310 -260; 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 31310 -260; BR 31310-260
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7252042
• MDR Text Key: 99359942
• Report Number: 3001883144-2018-00019
• 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: 02/18/2018

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: Physician
• Device Expiration Date: 05/17/2016
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: 3747234
• Other Device ID Number: 05414734027526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 02/09/2018
• Supplement Dates FDA Received: 02/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2012
• 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