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

Catalog Number E100-33M-00

Device Problem Hole In Material (1293)

Patient Problem No Code Available (3191)

Event Date 12/12/2017

Event Type  malfunction  

Event Description

A 33 mm st-jude epic mitral valve was implanted.But a hole was discovered on the valve after implantation.So the valve was removed and replaced by another 33 mm st-jude epic mitral valve.The explanted valve was ordered to be sent to pathology for gross only, then to risk management, then to the or materials management, and then to the vendor.Manufacturer response: for mitral stented tissue valve, epic¿ mitral stented tissue valve with linx¿ ac technology (per site reporter).We have heard nothing back.

• Brand Name: EPIC
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 county road b, east; saint paul MN 55117
• MDR Report Key: 7209628
• MDR Text Key: 97904514
• Report Number: 7209628
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: E100-33M-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR