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

Model Number ESP100-19

Device Problems Calcified (1077); Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problems Calcium Deposits/Calcification (1758); Dyspnea (1816); Valvular Stenosis (2697)

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

This was reported through a lit article titled: early calcific degeneration of the st.Jude medical epic aortic bioprosthesis.On an unknown date a 19mm epic valve was implanted in a 60 year old female.During 6 month post-op follow-up appointment an echocardiogram was performed and increase gradient was noted.The patient reported worsening of shortness of breath.18 months post implant, an echocardiogram was performed and stenosis and increase gradient was reported.The decision was made to explant the valve.During explant procedure, leaflets were found to be stenotic and multiple calcification nodules were present.The valve was replaced with a 21mm epic valve.The patient was reported stable post procedure.

Manufacturer Narrative

As reported in a research article a patient experienced shortness of breath and an increase in gradient so the epic valve was explanted, and it was noted that the leaflets were stenotic and calcifications were present.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• 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: 10242421
• MDR Text Key: 197926341
• Report Number: 3001883144-2020-00065
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESP100-19
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR