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

Model Number EVOLUTR-23

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Calcium Deposits/Calcification (1758); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Low Cardiac Output (2501); Valvular Insufficiency/ Regurgitation (4449)

Event Date 01/18/2022

Event Type  Injury  

Event Description

Medtronic received information via literature regarding extensive calcification of the mitral valve annulus in transcatheter aortic valve implants.All data were collected from a single center between november 2018 and september 2019.The study population included 305 patients who were predominantly male with a mean age of 80 years.Multiple manufacturer¿s devices were implanted in the study population; 22 were implanted with a medtronic evolut r bioprosthetic valve.No unique device identifier numbers were provided.Among all patients, adverse events included: stroke, low cardiac output, arrhythmia, and moderate paravalvular leak (pvl).Based on the available information medtronic product may have been associated with the adverse events.No additional adverse patient effectsor product performance issues were reported.

Manufacturer Narrative

Citation: haensig et al.Extensive calcification of the mitral valve annulus in transcatheter aortic valve implants.Interact cardiovasc thorac surg.2022 jan 18;34(2):167-175.Doi: 10.1093/icvts/ivab235.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC VALVE
• Type of Device: 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: 16382177
• MDR Text Key: 309614205
• Report Number: 2025587-2023-00545
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2023

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
• Device Operator: Health Professional
• Device Model Number: EVOLUTR-23
• Device Catalogue Number: EVOLUTR-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 02/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Male