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

Model Number EVOLUTR-29

Device Problems Material Split, Cut or Torn (4008); Central Regurgitation (4068)

Patient Problems Chest Pain (1776); Dyspnea (1816); Cusp Tear (2656); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/01/2023

Event Type  Injury  

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.  select patient information cannot be documented in the file due to regional privacy regulations.  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 at the time of the initial implant of this 29 millimeter (mm) transcatheter bioprosthetic valve, it had been implanted within a 27 mm non-medtronic surgical aortic valve.That valve-in-valve (viv) procedure was reported as successful and uneventful.There was no pre or post dilatation performed during the procedure.Following this replacement procedure, the mean gradient was 8.8 millimeters of mercury (mm hg).Aortic insufficiency and paravalvular leak (pvl) were not present at that time.Approximately 6 years and 2 months following this previously viv, the patient was admitted to the hospital as severe central aortic insufficiency was identified.There was question of a torn leaflet.Approximately 5 days later, the medtronic transcatheter valve was revised with a non-medtronic 26 mm transcatheter valve.As reported, there were no complications during or following the procedure.No additional adverse patient effects were reported.

Manufacturer Narrative

Updated: b3, b5, h6 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 at the time of the initial implant of this 29 millimeter (mm) transcatheter bioprosthetic valve, it had been implanted within a 27 mm non-medtronic surgical aortic valve.That valve-in-valve (viv) procedure was reported as successful and uneventful.There was no pre or post dilatation performed during the procedure.Following this replacement procedure, the mean gradient was 8.8 millimeters of mercury (mm hg).Aortic insufficiency and paravalvular leak (pvl) were not present at that time.Approximately 6 years and 2 months following this previously viv, the patient was admitted to the hospital as severe central aortic insufficiency was identified.There was question of a torn leaflet.Approximately 5 days later, the medtronic transcatheter valve was revised with a non-medtronic 26 mm transcatheter valve.As reported, there were no complications during or following the procedure.No additional adverse patient effects were reported.Additional information was received that shortness of breath and chest pain developed as a result of the aortic insufficiency (ai) six years post-implant.The patient was hospitalized approximately six years and one month post-implant and the severe ai was identified three days later.A torn leaflet was not visualized but presumed based on clinical history and imaging.

• 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: 18161707
• MDR Text Key: 328422391
• Report Number: 2025587-2023-04814
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVOLUTR-29
• Device Catalogue Number: EVOLUTR-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2023
• 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): Required Intervention; Hospitalization