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

Model Number EVOLUTR-34-C

Device Problem Perivalvular Leak (1457)

Patient Problems High Blood Pressure/ Hypertension (1908); Viral Infection (2248); Valvular Insufficiency/ Regurgitation (4449); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 06/07/2022

Event Type  Injury  

Event Description

Medtronic received information that approximately 5 years and 2 months following the implant of this transcatheter bioprosthetic valve an echocardiogram identified mild-moderate paravalvular leak (pvl) with no evidence of stenosis.A mean gradient of 12 millimeters of mercury (mmhg) and acceleration time (at) of <(><<)>100 seconds were measured.No treatment reported.Approximately 5 months later, a covid-19 infection was identified.Medication and hospitalization were required.Two days later an echocardiogram identified moderate pvl with no significant stenosis.¿mildly¿ elevated velocities at the end of the study measured 2.8 meters per second (m/s).This was reported likely related to increased flow.A short at was noted; specific value not provided.The following day a blood was obtained which detected staphylococcus species, s.Epidermidis, and methicillin-resistant (mr) staphylococci (meca/c) via polymerase chain reaction (pcr) testing.The next day an additional echocardiogram noted moderate-severe aortic regurgitation.However, at that time it was unable to discern if this was pvl or transvalvular regurgitation.The gradients across the transcatheter valve were reported as elevated; specific values not provided.This elevation was noted as possibly related to the high output and the ¿significant¿ aortic regurgitation.Compared with the previous study, the left ventricular function was now hyperdynamic.Additionally, possible severe tricuspid regurgitation (tr) with moderate pulmonary hypertension (ph) also noted.The following day, sputum culture identified > 10 squamous epithelials with lower power field (lpf), occasional neutrophils, many gram positive cocci, with a few gram negative rods.This same day, the patient died.The death was reported as a non-cardiac death associate with the covid-19 infection.As reported, there was a possibility that ¿high output failure¿ could have been a result of sepsis (endocarditis) related to covid 19 infection.Endocarditis was not diagnosed.Vegetation was not noted on imaging.There was no medical history of endocarditis.The physician reported the death was not related to the valve.

Manufacturer Narrative

This report is being submitted as part of a retrospective review and remediation per (b)(4).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.

Manufacturer Narrative

Previous report(s) in this series should have contained the following narrative text: "this report is being submitted as part of a retrospective review and remediation for capa 564121 per (b)(4)." 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
• 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: 18914798
• MDR Text Key: 337790937
• Report Number: 2025587-2024-01698
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2019
• Device Model Number: EVOLUTR-34-C
• Device Catalogue Number: EVOLUTR-34-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/03/2024
• Date Device Manufactured: 03/30/2017
• 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
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 90 KG