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

Model Number MITRAL

Device Problems Defective Component (2292); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2020

Event Type  malfunction  

Event Description

Epic valve - mitral valve - placed and described as "defective" per surgeon.Removed and replaced with additional mitral valve of same 29mm size.Valve was sent to pathology and labeled as defective per clinical charge nurse.

• 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: 9699355
• MDR Text Key: 178754126
• Report Number: 9699355
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MITRAL
• Device Catalogue Number: E100-29M-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA