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

Model Number	MITRAL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After valve was implanted, holder fell apart.Fda safety report id#:(b)(4).

• Brand Name: EPIC
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. / ST. JUDE MEDICAL COSTA RICA LTDA.
• MDR Report Key: 13847463
• Report Number: MW5108384
• Device Sequence Number: 16585353
• Product Code: LWR
• UDI-Device Identifier: 05414734055604
• UDI-Public: 05414734055604
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2023
• Device Model Number: MITRAL
• Device Catalogue Number: E100-31M-00
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male