MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; REPLACEMENT HEART-VALVE

Model Number	305U221
Medical Device Problem Codes	Gradient Increase (1270); Patient Device Interaction Problem (4001); Thickening of Material (4056); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Heart Failure/Congestive Heart Failure (4446)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that 6 years and 10 months post implant of this 21mm bioprosthetic aortic valve, transesophageal echocardiogram (tee) showed an aortic valve mean gradient of 34.5mmhg and a peak gradient of 60.8mmhg.Aortic valve area was measured to be 0.8 cm^2.The report indicated ¿tee images suggesting some degree of ingrowth into the valve versus patient prosthesis mismatch.¿ at the time the patient¿s body surface area was 2.3.Seven months later, a transthoracic echocardiogram (tte) was performed which showed severe aortic stenosis with a peak velocity of 4.3m/s, mean gradient of 37mmhg and an aortic valve area of 0.8sqcm.Additionally, it was reported that there were ¿moderately thickened cusps¿.It was also reported that the patient developed "several health related issues, one of which was heart failure".A computerized tomography (ct) angiogram was performed at this time to evaluate the patient for potential transcatheter valve-in-valve replacement.No intervention or adverse patient effects were reported.
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.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: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Common Device Name: REPLACEMENT HEART-VALVE
• 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: 21195137
• Report Number: 2025587-2025-00488
• Device Sequence Number: 12847411
• Product Code: DYE
• UDI-Device Identifier: 00643169001848
• UDI-Public: 00643169001848
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2019
• Device Model Number: 305U221
• Device Catalogue Number: 305U221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 01/21/2025
• Date Device Manufactured: 07/25/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 113 KG