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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Hemolysis (1886); Renal Failure (2041); Thromboembolism (2654); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturing reference number 3001883144-2021-00088.An article "durability of mitral valve replacement with a 3rd generation bioprosthesis", was reviewed.This research article is a retrospective single center experience to evaluate the durability of a third-generation porcine bioprosthesis (epic valve) in the mitral position, according to patients¿ age at surgery.Epic valve (abbott) was associated with the study.The article concluded the epic bioprosthesis showed good durability at 5 to 10 years in the mitral position.The primary and correspondence author of the article is amedeo anselmi, md, phd, division of thoracic and cardiovascular surgery, pontchaillou university hospital, 2 rue henri le guilloux, 35000 rennes, france , with the email amedeo.Anselmi@chu-rennes.Fr.

Manufacturer Narrative

As reported in a research article, 482 patients underwent mitral valve replacement using an epic valve between 2009 and 2018.Events of stroke, renal failure, reoperation, nonstructural valve dysfunction, structural valve dysfunction, endocarditis, regurgitation, hemolysis, thromboembolic events, perivalvular leak, and global left atrial thrombosis 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.

• 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
• MDR Report Key: 11967217
• MDR Text Key: 255155423
• Report Number: 3001883144-2021-00087
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR