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 Backflow (1064); Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Aortic Valve Stenosis (1717); Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/10/2021

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2012, that a patient underwent an aortic valve replacement (avr) and replacement of ascending aorta due to dissection of the ascending aorta.A 19 mm epic supra valve w/flexfit was implanted in aortic position.On an unknown date a year ago, severe aortic stenosis causing cardiac insufficiency was confirmed as well as an elevation of the pressure gradient was also observed.On (b)(6) 2021, a redo avr was performed.The 19 mm epic supra valve w/flexfit was explanted and a 23 mm non-abbott device was implanted to resolve the event.Visual inspection of the explanted valve showed pannus formation and thrombus that restricted the leaflet mobility.The patient remained hemodynamically stable throughout the procedure and is currently in stable condition.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

Explant due to severe aortic stenosis causing cardiac insufficiency was reported.The investigation found that there was fibrous pannus ingrowth on the inflow surface and circumferential with narrowing of inflow diameter.There was limited mobility of cusps.The outflow thrombus was observed on all cusps.Cusp 2 had horizontal fold/retraction with incomplete coaptation.There was fibrous thickening on cusp 1.There was calcifications present within pannus and no acute inflammation was observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The immobilizing thrombus on the outflow of the cusps would have contributed to the reported stenosis.The immobilizing thrombus on the outflow of the cusps and calcification would have contributed to the reported stenosis.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13002888
• MDR Text Key: 282232245
• Report Number: 3001883144-2021-00149
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2016
• Device Model Number: ESP100-19
• Device Lot Number: 3840891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2012
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 65 KG