MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC FREESTYLE AORTIC VALVE SIZER 29 MM

Model Number 7990

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2021

Event Type  malfunction  

Event Description

During the procedure, ascending aorta replacement, freestyle sizers are used to size the aorta.The sizer was being loaded on to the handle, as was tightened the sizer broke in 2 pieces.This sizer had not been used.

• Brand Name: MEDTRONIC FREESTYLE AORTIC VALVE SIZER 29 MM
• Type of Device: AORTIC VALVE SIZER
• Manufacturer (Section D): MEDTRONIC; minneapolis MN
• MDR Report Key: 11379649
• MDR Text Key: 233984034
• Report Number: 11379649
• Device Sequence Number: 1
• Product Code: DTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/09/2021

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
• Device Operator: Health Professional
• Device Model Number: 7990
• 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: 02/09/2021
• Distributor Facility Aware Date: 02/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 128