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

Device Problem Perivalvular Leak (1457)

Patient Problems Atrial Fibrillation (1729); Hemorrhage/Bleeding (1888); Renal Failure (2041); Thromboembolism (2654); Thrombosis/Thrombus (4440); Valvular Insufficiency/ Regurgitation (4449)

Event Type  Injury  

Manufacturer Narrative

In an research article, post-operative paravalvular leak, stroke, renal failure, atrial fibrillation, pacemaker implant, bleeding/transfusion, thromboembolism, re-intervention, thrombosis and transvalvular regurgitation were reported.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.

Event Description

The article, "incidence of valvular regurgitation and leaflet perforation by using automated titanium fasteners (corknot®) in heart valve repair or replacement: less usual than reported", was reviewed.This research article is a retrospective single study experience to investigate the incidence of valvular complications in patients where corknot was used and draw preliminary conclusions on the risks involved in using automated titanium suture fasteners in cardiac valve replacement and/or repair surgeries.Perimount magna ease valve, abbott trifecta gt aortic valve, medtronic mosaic valve, medtronic hancock ii valve, abbott epic valve, medtronic avalus valve, ats mechanical valve, and st jude mechanical valve were associated with the study.The article concluded that the feasibility of corknot® utilization in mitral and aortic valve surgeries.Additionally, incidence of corknot® related complications in heart valve repair or replacement surgery is less usual in our setting than previously reported.These results motivate the use of corknot® as a valid alternative with complete commitment.[the primary author of the article is faizus sazzad, md, department of cardiac, thoracic and vascular surgery, national university heart centre, 1e kent ridge road, singapore 119228, singapore, the correspondence author is theo kofidis, md, with corresponding email : tkofidis@yahoo.Com] related manufacturing reference numbers: 2648612-2021-00083 and 3008452825-2021-00403.

• Brand Name: EPIC STENTED TISSUE VALVE
• 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: 12248930
• MDR Text Key: 267463733
• Report Number: 3001883144-2021-00112
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/29/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR