MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVOLUTR-29-US
Medical Device Problem Codes	Gradient Increase (1270); Perivalvular Leak (1457); Patient Device Interaction Problem (4001); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	12/01/2022
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 4 years and 1 month following the implant of this transcatheter bioprosthetic valve, an increased gradient was noted, and a possible thrombus was revealed on a computed tomography scan.The patient was provided blood thinning medication.Approximately 1 years and 6 months following the later, an echocardiogram revealed an ascending aorta of 0.6 mm, vmax 5.0, a mean gradient of 16 mmhg, moderate aortic insufficiency, and mild to moderate paravalvular leak.Device stenosis was also noted.The patient's blood thinning medication was changed to a new medication.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.
Event or Problem Description
Medtronic received information that approximately 4 years and 1 month following the implant of this transcatheter bioprosthetic valve, an increased gradient, and possible thrombus were revealed on a computed tomography scan.The patient was provided blood thinning medication.Approximately 1 years and 6 months following the later, an echocardiogram revealed an aortic valve area of 0.6 cm2, aortic valve maximal velocity of 5.0 m/s, a mean gradient of 16 mmhg, moderate aortic insufficiency, and mild to moderate paravalvular leak.Device stenosis was also noted.The patient's blood thinning medication was changed to a new medication.No additional adverse patient effects were reported.
Event or Problem Description
Medtronic received information that approximately 4 years and 1 month following the implant of this transcatheter bioprosthetic valve, an increased gradient, and possible thrombus were revealed on a computed tomography scan.The patient was provided blood thinning medication.Approximately 1 years and 6 months following the later, an echocardiogram revealed an aortic valve area of 0.6 cm2, aortic valve maximal velocity of 5.0 m/s, a mean gradient of 16 mmhg, moderate aortic insufficiency, and mild to moderate paravalvular leak.Device stenosis was also noted.The patient's blood thinning medication was changed to a new medication.No additional adverse patient effects were reported.Additional information was received which indicated that a thrombus was not confirmed.Additionally, the mean gradient was noted to be 60 mmhg via echocardiography.
Additional Manufacturer Narrative
Updated data: b5.Second paragraph added.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: EVOLUT R TRANSCATHETER AORTIC VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• 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: 19905759
• Report Number: 2025587-2024-04428
• Device Sequence Number: 8618538
• Product Code: NPT
• UDI-Device Identifier: 00763000017675
• UDI-Public: 00763000017675
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 08/28/2024

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 Expiration Date: 03/29/2020
• Device Model Number: EVOLUTR-29-US
• Device Catalogue Number: EVOLUTR-29-US
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 08/14/2024; 08/22/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 08/22/2024; 08/28/2024
• Date Device Manufactured: 04/17/2018
• 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
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 72 KG