MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number E100-25M

Device Problem Backflow (1064)

Patient Problems Left Ventricular Dysfunction (1947); Mitral Regurgitation (1964); Chronic Obstructive Pulmonary Disease (COPD) (2237)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, two patients had an epic valve was replaced due to regurgitation.The results of the investigation are inconclusive since a valve-in-valve procedure was performed and the device was not accessible for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported through the japanese association for thoracic surgery, 2019.This research article identifying abbotts epic stented, bio prosthesis, 25mm porcine heart valve w/flexfit system that may be related to a recent valve in valve procedure.Specific patient information is documented as (b)(6) years old female.Details are listed in the attached article, its titled "early outcomes of transcatheter mitral valve replacement for degenerated bio prosthesis in japanese (mitral viv study): a four-case series." the event describes regurgitation was seen in patients implanted with a epic bio prosthesis (25mm), so mitral valve-in-valve was applied.After the previous surgical, left ventricular dysfunction occurred, and intense adhesions around the cardiac apex were seen when a temporary left ventricular assist device was used.Mitral valve in valve procedure was successful and discharged.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); 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. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9864746
• MDR Text Key: 187625825
• Report Number: 3001883144-2020-00020
• 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: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/23/2020

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
• Device Model Number: E100-25M
• Device Catalogue Number: E100-25M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/23/2020
• 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): Other; Required Intervention
• Patient Age: 69 YR