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

Model Number EVOLUTR-29

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Pleural Effusion (2010); Pulmonary Edema (2020); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577)

Event Date 12/12/2021

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device 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.Select patient information cannot be included in regulatory report 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 approximately 4 years and 2 months following the implant of this transcatheter bioprosthetic valve, the patient presented at the emergency department with report of chest pressure that had occurred for approximately 6 hours.While hospitalized, an electrocardiogram (ecg) identified non-specific st depression and a rising troponin measured 0.0, 0.10, 0.11 and 0.07.A non-st elevation myocardial infarction (nstemi) was reported.2+ bilateral pedal edema note with report of congestive heart failure (chf).The following day xarelto was held, aspirin, plavix and enoxaparin were administered (therapeutic anti-coagulation).Ecg monitoring continued.Repeat troponin and chest x-ray were performed within 24 hours and were trended down.Regarding the nstemi, the patient became completely asymptomatic and stable.The nstemi was considered resolved 4 days following onset.Additionally, during the hospitalization, the patient was treated for congestive heart failure.A chest x-ray showed clearing with note of small bilateral pleural effusions again with bibasal atelectasis.There was mild diffuse interstitial prominence throughout both lungs predominantly of right lung.As reported, these could represent chronic interstitial changes verse mild interstitial pulmonary edema.Two days following onset of chf, the chest x-ray noted resolving chf.Vascular redistribution noted and improved.Blunting of the costophrenic angles was again noted but had improved on the left side.Lung parenchymal changes at the right lung base were similar as previous.The patient was discharged home.  of note, the physician reported that nstemi and congestive heart failure were considered possibly related to the valve.No further information was provided.

Event Description

Additional information was received that an echocardiogram was performed approximately three years, nine months following valve implant and the valve was reported to be functioning as expected, no issues were observed.During the patient's hospital admission approximately 6 months later, it was noted the chf may have triggered the st-elevation and troponin increase.Per the physician, an exacerbation of chf could not be ruled out as an echocardiogram was not performed and the valve was not investigated to determine whether it was still functioning as expected.The physician indicated the patient had underlying heart disease which required the transcatheter bioprosthetic valve implant.No additional adverse patient effects were reported.

Manufacturer Narrative

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: 15874564
• MDR Text Key: 304420649
• Report Number: 2025587-2022-03332
• 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: 01/19/2023

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 Expiration Date: 08/29/2018
• Device Model Number: EVOLUTR-29
• Device Catalogue Number: EVOLUTR-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 01/19/2023
• Date Device Manufactured: 09/18/2017
• 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): Required Intervention; Hospitalization