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

Model Number	305U27
Medical Device Problem Codes	Calcified (1077); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008); Thickening of Material (4056); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Medtronic received information that approximately 12 years and 4 months post implant of this 27mm aortic bioprosthetic valve, it was explanted and replaced with a bioprosthetic valve of different model.The reason for the replacement was not reported.No additional adverse patient effects were reported.
Event or Problem Description
Medtronic received additional information which stated that the reason for the replacement was severe chronic aortic regurgitation (ar).It was stated that during explant of the valve, it was observed that one valve leaflet was missing entirely and the other two leaflets were badly degenerated with microcalcified commissures, minor thrombus and cracks.It was noted that the patients native annulus was also calcified.Pannus was also observed.
Additional Manufacturer Narrative
Updated b1 updated b2 updated b3 updated b5 updated b7 updated d6b updated e updated h6 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
• 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: 20241481
• Report Number: 2025587-2024-05212
• Device Sequence Number: 15444089
• Product Code: DYE
• UDI-Device Identifier: 00885074253268
• UDI-Public: 00885074253268
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 305U27
• Device Catalogue Number: 305U27
• 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: 09/06/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 12/04/2024
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male