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

Model Number MITRAL

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2020

Event Type  malfunction  

Event Description

During a open heart valve procedure, after the surgeon had asked for the heart valve to be opened onto the field, the scrub tech noticed that the valve was defective.The scrub tech noticed that one of the leaflets was not working.They asked surgeon to look at it and he confirmed that the valve was defective.Defective valve was immediately taken off table and new valve was opened.All of this happened before the valve was even tried to be implanted into patient.

• Brand Name: EPIC
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10127784
• MDR Text Key: 194358109
• Report Number: 10127784
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MITRAL
• Device Catalogue Number: E100-33M-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Weight: 65