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

Model Number	40023
Medical Device Problem Codes	Perivalvular Leak (1457); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pleural Effusion (2010); Septic Shock (2068); Cardiogenic Shock (2262); Valvular Insufficiency/ Regurgitation (4449)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that 4 months post implant of this 23mm aortic bioprosthetic valve, it was explanted and replaced with a bioprosthetic valve of the same size and model.The reason for the replacement was not reported.No additional adverse patient effects were reported.Additional information was received which stated that the reason for the replacement was sepsis with septic shock, endocarditis, aortic insufficiency (ai), and annular dehiscence with a peak gradient of 29mmhg.It was stated that the organism cultured was staphylococcus aureus bacteremia.It was reported that a mobile echo density was observed on the aortic surface of the valve on transesophageal echocardiogram (tee).The presence of vegetation was also reported.Antibiotics were administered.It was reported that immediately after valve replacement, the patient was in a mixed shock state concerning for cardiogenic as well as septic shock.Medication was administered to treat the hemodynamic instability.The patient was administered pressor medications and was on mechanical ventilation support post valve replacement procedure.It was also stated that a trivial paravalvular leak was noted on transesophageal echocardiogram (tee) post procedure.It was further noted that a small left pleural effusion had also been observed.No additional adverse patient effects were reported.
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.

• Brand Name: AVALUS AORTIC TISSUE VALVE
• Common Device Name: 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: 19558046
• Report Number: 2025587-2024-03494
• Device Sequence Number: 4851621
• Product Code: LWR
• UDI-Device Identifier: 00643169983199
• UDI-Public: 00643169983199
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P170006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 06/18/2024

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: 03/08/2026
• Device Model Number: 40023
• Device Catalogue Number: 40023
• 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: 06/11/2024
• Initial Report FDA Received Date: 06/18/2024
• Date Device Manufactured: 03/09/2023
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Race: White