MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC¿ SUPRA VALVE (AORTIC); HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number ESP100-23

Device Problems Calcified (1077); Patient-Device Incompatibility (2682); Device Stenosis (4066)

Patient Problems Aneurysm (1708); Aortic Valve Stenosis (1717)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on an unknown date in 2013, a 23mm epic supra valve was implanted in the patient.The annulus diameter was 23mm.On the beginning of (b)(6) 2024, a valve failure was diagnosed by imaging.The patient had high gradient of 50mmhg and aorta aneurism was diagnosed.On (b)(6) 2024, the valve was explanted due to calcification of the valve.An annulus enlargement was done surgically and a new 25mm epic supra was implanted.Cthe explanted valve had pannus formation and calcification of leaflets.The patient was reported stable after the implant of new 25mm epic supra valve.The patient was reported recovering.

• Brand Name: EPIC¿ SUPRA VALVE (AORTIC)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18918533
• MDR Text Key: 337843512
• Report Number: 2135147-2024-01156
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ESP100-23
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female