MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC HANCOCK II T510 MITRAL VALVE; REPLACEMENT HEART-VALVE

Model Number T510C33

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

Event Description

The scrub nurse was unable to properly attach the valve in the valve holder device.The first assistant was also unable to do the same.A second valve was put on the filed with no issues with the valve holder.The failed valve never reached the patient.

• Brand Name: MEDTRONIC HANCOCK II T510 MITRAL VALVE
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 11337148
• MDR Text Key: 232177784
• Report Number: 11337148
• Device Sequence Number: 1
• Product Code: DYE
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T510C33
• Device Catalogue Number: T510C33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13140 DA