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

Model Number EVOLUTR-34

Device Problems Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Dyspnea (1816); Pleural Effusion (2010); Cardiogenic Shock (2262); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451); Renal Impairment (4499)

Event Date 04/08/2022

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product remains implanted, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that approximately four years and 11 days following the implant of this transcatheter bioprosthetic valve an echocardiogram identified a reduced left ventricular ejection fraction of 35-40% with increased left ventricular dilation.Moderate aortic regurgitation and moderate paravalvular leak (pvl) was reported.In addition, increased mitral regurgitation, increased right ventricular systolic pressure (rvsp) and right atrial pressure (rap) were also observed.The right ventricle was mildly dilated with mildly reduced systolic function.Four years and four and a half months post implant, a transesophageal echocardiogram (tee) again showed dilated right and left ventricles, a well seated bioprosthetic aortic valve, moderate mitral and moderate tricuspid regurgitation and a small echogenic mass with attachment to the left ventricular outflow tract (lvot).Endocarditis and vegetation was suspected.The patient was admitted to the hospital due to a congestive heart failure (chf) exacerbation.Approximately four days after hospitalization, a pulseless electrical activity (pea) arrest followed by ventricular tachycardia occurred.Cardiopulmonary resuscitation (cpr) was initiated and resulted in return of spontaneous circulation.Per the physician, the pea arrest was due to the congestive heart failure (chf) exacerbation.Antibiotics were administered for suspected endocarditis; however blood cultures were negative and endocarditis was not confirmed.Severe aortic regurgitation and moderate mitral and tricuspid regurgitation were noted.Diuretics and inotropes were administered.One day after the pea arrest an acute kidney injury was reported likely due to cardiogenic shock.Five days later a repeat transcatheter aortic valve implant occurred.It was reported the second valve was implanted due to the regurgitation.No additional adverse patient effects were reported.

Manufacturer Narrative

Corrected data: e1 phone number and h6 device code.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 15319761
• MDR Text Key: 298874720
• Report Number: 2025587-2022-02406
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2018
• Device Model Number: EVOLUTR-34
• Device Catalogue Number: EVOLUTR-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• Date Device Manufactured: 10/30/2017
• 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; Required Intervention