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 Bacterial Infection (1735); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Renal Failure (2041); Heart Failure/Congestive Heart Failure (4446)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, 467 patients underwent bioprosthetic mitral valve replacement with bovine pericardial valves (356) and porcine valves (111), between january 2007 and december 2018.The epic stented tissue valve was used in a total of 84 patients.Events of bleeding, reoperation, ischemic stroke, acute kidney injury, prolonged ventilation, sternal infection, pacemaker implantation, and heart failure 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

Related manufacturing reference number: 3001883144-2021-00103.The article, "comparison of porcine versus bovine pericardial bioprosthesis in the mitral position", was reviewed.This research article is a retrospective single center experience to examine perioperative and midterm outcomes of bioprosthetic valve choice, porcine or bovine pericardial, in the mitral position, focusing on 25-mm valves.Carpentier-edwards perimount (edwards lifesciences), epic stented tissue valve (abbott) and medtronic mosaic (medtronic) were associated with the study.The article concluded that the choice of a porcine or bovine pericardial bioprosthesis does not affect midterm survival and cardiac death.The primary and correspondence author of the article is hideki tsubota, md, phd, department of cardiovascular surgery, kokura memoria hospital, asano 3-2-1, kokura kita-ku, kitakyushu, fukuoka 802-8555, japan with the corresponding email: tsubota07@gmail.Com.

• 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: 12084896
• MDR Text Key: 258958820
• Report Number: 3001883144-2021-00102
• 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,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2021

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?: No
• 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: 06/01/2021
• Initial Date FDA Received: 06/29/2021
• 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): Required Intervention
• Patient Age: 74 YR