MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 995CS27

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2015

Event Type  Injury  

Manufacturer Narrative

This report includes information previously submitted as part of the alternative summary report filed on 2016-april-28 by medtronic under expired asr reporting authorization number (b)(4) and includes supplemental information received by medtronic.Any additional information received regarding this device report will be submitted as a supplement to this report.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information that thirteen years, three months post implant of this bioprosthetic valve, this valve was replaced valve-in-valve with a medtronic transcatheter valve due to elevated gradients resulting from aortic stenosis (as).No adverse patient effects were reported.Additional information was received that reported after an unknown duration post implant of the 25mm aortic bioprosthetic valve, it was explanted and replaced with another manufacturers product.The reason for replacement was not reported.No additional adverse patient effects were reported.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19004702
• MDR Text Key: 338936693
• Report Number: 2025587-2024-01946
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00681490219198
• UDI-Public: 00681490219198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 995CS27
• Device Catalogue Number: 995CS27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male