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

Model Number E100-29M

Device Problem Material Perforation (2205)

Patient Problems Atrial Fibrillation (1729); Mitral Regurgitation (1964)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

An event of atrial fibrillation following the initial procedure, with later valve explant due to leakage was reported.The reported 'perforation' was confirmed.Cusp 1 contained a tear in its base.There was thinning of the bases of all three cusps.Fibrous pannus ingrowth was present on the outflow surface of cusp 3.All three cusps contained a thin layer of fibrin.No acute inflammation or significant calcifications were found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported event could not be conclusively determined.Atrial fibrillation, which was noted upon initial implant, is a potential contributing factor for mitral regurgitation.Furthermore, the aforementioned fibrous pannus ingrowth could have potentially altered the distribution of stress along the bases of the leaflets and hindered durability of the valve.

Event Description

On (b)(6) 2017, a mitral valve replacement (mvr) was performed and this 29mm epic valve was implanted in the patient's mitral position using non-everting mattress sutures with pledgets.On (b)(6) 2019, acute cardiac failure was confirmed to be advancing.An echocardiography was performed and it revealed a leakage in the mitral position.The patient was reported to have developed atrial fibrillation (af) after initial procedure.Meanwhile, the peak velocity was noted to be 1.2 m/s.A re-do mvr was scheduled on (b)(6) 2019 and a carpentier-edwards perimount magna ease mitral heart valve will be used as a replacement.According to the surgeon, a perforation was observed on a cusp of this valve through the echocardiogram.

Event Description

On (b)(6) 2017, a mitral valve replacement (mvr) was performed and this 29mm epic valve was implanted in the patient's mitral position using non-everting mattress sutures with pledgets.On (b)(6) 2019, acute cardiac failure was confirmed to be advancing.An echocardiography was performed and it revealed a leakage in the mitral position.The patient was reported to have developed atrial fibrillation (af) after initial procedure.Meanwhile, the peak velocity was noted to be 1.2 m/s.A re-do mvr was performed on (b)(6) 2019 and a carpentier-edwards perimount magna ease mitral heart valve will be used as a replacement.According to the surgeon, a perforation was observed on a cusp of this valve through the echocardiogram.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 8630042
• MDR Text Key: 145735062
• Report Number: 3001883144-2019-00047
• 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
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: E100-29M
• Device Catalogue Number: E100-29M
• Device Lot Number: BR00009441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR