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

Model Number E100-21A

Device Problems Backflow (1064); Calcified (1077); Obstruction of Flow (2423)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 06/03/2021

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 a patient that had a 21 mm epic valve implanted in 2011, now required a valve in valve procedure for aortic stenosis and aortic insufficiency.On (b)(6) 2021 a 23 mm portico valve was placed successfully.No patient consequences reported.No additional information provided.

Manufacturer Narrative

Additional information: b5, g3, g6, h2, h6, h10.An event of stenosis, regurgitation, and calcification was reported.A more comprehensive assessment could not be performed as a valve-in-valve was performed and the device remains implanted was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the instructions for use of the portico valve (b)(4) revision a "the portico¿ valve is designed to be implanted in the native aortic heart valve without open heart surgery and without concomitant surgical removal of the failed native valve.".

Event Description

Subsequently to the initially filed information, the following information was received on (b)(6) 2021.It was reported that calcification was a cause for the patients aortic insufficiency.

• 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.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 11976289
• MDR Text Key: 255487190
• Report Number: 3001883144-2021-00089
• 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: 08/26/2021

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 Model Number: E100-21A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 06/10/2021
• Supplement Dates Manufacturer Received: 08/09/2021
• Supplement Dates FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention