MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC FREESTYLE BIOPROSTHESIS 27MM; AORTIC VALVE

Model Number 55432

Device Problem Material Perforation (2205)

Patient Problem Insufficiency, Valvular (1926)

Event Date 04/01/2019

Event Type  Death  

Event Description

Freestyle graft/implant failed, which required removal and new implant used.Failure caused extended bypass time.

• Brand Name: MEDTRONIC FREESTYLE BIOPROSTHESIS 27MM
• Type of Device: AORTIC VALVE
• Manufacturer (Section D): MEDTRONIC ; 710 medtronic parkway; minneapolis MN
• MDR Report Key: 8569389
• MDR Text Key: 143729454
• Report Number: 8569389
• Device Sequence Number: 1
• Product Code: LWQ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2023
• Device Model Number: 55432
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2019
• Distributor Facility Aware Date: 04/01/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2019
• 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 Outcome(s): Death
• Patient Age: 71 YR
• Patient Weight: 134