MAUDE Adverse Event Report: MEDTRONIC, INC. AORTIC AP; HEART-VALVE, MECHANICAL

Model Number	505DA20
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Chest Pain (1776); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	09/03/2024
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that 3 years and 8 months post implant of this 20mm aortic mechanical valve and 27mm mitral mechanical valve, they were explanted and replaced with a 23mm aortic bioprosthetic valve and 27mm mitral bioprosthetic valve respectfully.The reason for the replacement was not reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Updated b5 updated b7 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.
Event or Problem Description
Medtronic received additional information which stated that the reason for the replacement was due to a large thrombus on the mechanical valves, severe mitral stenosis, moderate to severe aortic stenosis.Non compliance with anticoagulants was noted.It was mentioned that the patient had presented with hypotension, chest pain, and shortness of breath.It was reported that after removing the mitral valve, it was observed that the posterior mitral annulus looked thin, therefore, a bovine pericardial patch was sutured to it.It was stated that the patient had a small aortic annulus, therefore, a root enlargement with a y incision technique was performed.Pannus below the aortic annulus was observed during removal of the mechanical valve.It was noted that when the replacement 23mm aortic valve was implanted that both coronary ostia were above the level of the valve and were visible after implantation.When coming off bypass, it was reported that there was a wall motion abnormality in right coronary artery distribution.It was mentioned that additional stitches to the aortotomy line had been performed which was closed to the orifice of rca.It was thought that there was an ischemia in the rca.A coronary artery bypass graft (cabg) was performed to ostial rca with a vein graft, however, rv function was still sluggish despite good flow through the graft.It was reported that the patient experienced post cardiotomy cardiogenic shock, right ventricular dysfunction, pulmonary edema and respiratory failure.A central right ventricular assist device (rvad) was implanted.It was mentioned that the patient was severely coagulopathic due to extended pump and cross clamp time and required several blood products and clotting factors and prolonged hemostasis.It was reported that the bleeding was coming from the aortotomy line.Multiple stitches and hemostasis agents were utilized.No additional adverse patient effects were reported.

• Brand Name: AORTIC AP
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20449415
• Report Number: 3008592544-2024-00083
• Device Sequence Number: 20594260
• Product Code: LWQ
• UDI-Device Identifier: 00643169335011
• UDI-Public: 00643169335011
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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): 12/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2023
• Device Model Number: 505DA20
• Device Catalogue Number: 505DA20
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/19/2024
• Date Device Manufactured: 06/04/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male