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

Model Number 40025

Device Problems Gradient Increase (1270); Patient Device Interaction Problem (4001); Device Stenosis (4066); Central Regurgitation (4068)

Patient Problems Aneurysm (1708); Aortic Valve Stenosis (1717); Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/26/2023

Event Type  Injury  

Event Description

Medtronic received information that 9 years post implant of this 25mm aortic bioprosthetic valve, non-obstructive valve thrombosis was observed.It was stated that the aortic mean gradient increased to 31 mmhg.Further examination via computed tomography (ct) discovered mild thickened and kinked leaflets.No additional adverse patient effects were reported.It was later reported that a transthoracic echocardiogram (tte) performed 5 months later showed moderate to severe aortic stenosis (as) and severe aortic regurgitation (ar).It was also stated that a aneurysm of the ascending aorta was observed.No additional adverse patient effects were reported.

Manufacturer Narrative

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 9 years post implant of this 25mm aortic bioprosthetic valve, non-obstructive valve thrombosis was observed.It was stated that the aortic mean gradient increased to 31 mmhg.Further examination via computed tomography (ct) discovered mild thickened and kinked leaflets.No additional adverse patient effects were reported.It was later reported that a transthoracic echocardiogram (tte) performed 5 months later showed moderate to severe aortic stenosis (as) and severe aortic regurgitation (ar).It was also stated that a aneurysm of the ascending aorta was observed.It was indicated that the aneurysm measures 48mm.No additional adverse patient effects were reported.

Manufacturer Narrative

Corrected b5 to include "it was indicated that the aneurysm measures 48mm." 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.

• Brand Name: AVALUS AORTIC TISSUE VALVE
• 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: 18985760
• MDR Text Key: 338693216
• Report Number: 2025587-2024-01930
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P170006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• 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: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2015
• Device Model Number: 40025
• Device Catalogue Number: 40025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Date Device Manufactured: 08/22/2014
• 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): Life Threatening
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 104 KG