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

Device Problems Leak/Splash (1354); Torn Material (3024)

Patient Problems Mitral Insufficiency (1963); Mitral Regurgitation (1964)

Event Date 04/12/2018

Event Type  Injury  

Event Description

Approximately 5 years ago, a mitral valve replacement (mvr) was performed and an epic valve (model and size unknown) was implanted.On an unknown date, the patient presented with symptoms of cardiac insufficiency, and mitral regurgitation (mr) was confirmed.On (b)(6) 2018, the valve was explanted and a re-do mvr was performed.Upon explant, a leaflet tear was observed.Additional information pending.

Manufacturer Narrative

The reported event of a torn cusp was confirmed.Mitral regurgitation was also reported.Morphological and histopathological examination revealed cusp 2 was torn and all cusps had areas of marked thinning and loss of collagen.No inflammation or significant calcifications were found.The cause of the torn cusp remains unknown.

Event Description

Approximately 5 years ago, a mitral valve replacement (mvr) was performed and an epic valve (model and size unknown) was implanted.On an unknown date, the patient presented with symptoms of cardiac insufficiency, and mitral regurgitation (mr) was confirmed.On (b)(6) 2018, the valve was explanted and a re-do mvr was performed.Upon explant, a leaflet tear was observed.All efforts were attempted to gain additional information and nothing was provided.

• Brand Name: EPIC STENTED TISSUE VALVE
• 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
• MDR Report Key: 7512630
• MDR Text Key: 108225859
• Report Number: 3001883144-2018-00040
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Date Manufacturer Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention