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

Model Number ESP100-21

Device Problems Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Thrombosis/Thrombus (4440)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that a 21mm epic supra valve was implanted in the patient on (b)(6) 2019.On (b)(6) 2019, the patient presented with dyspnea and general discomfort.Echo revealed stenosis in the valve with a gradient of 90mmhg.On (b)(6) 2019, the epic valve was explanted from the patient due to the structural deterioration of the valve.Upon explant, there was thrombus noted in the aortic valve that limited movement of the leaflets.The valve was replaced with a non-abbott valve and the patient is stable.No additional information was provided.

Manufacturer Narrative

An event of dyspnea, stenosis, gradient, structural valve deterioration, thrombus, and valve explant was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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: 11916225
• MDR Text Key: 253725352
• Report Number: 3001883144-2021-00076
• 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: 07/07/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2022
• Device Model Number: ESP100-21
• Device Lot Number: BR00017297
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR