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

Model Number EVPROPLUS-29US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969); Discomfort (2330)

Event Date 03/15/2021

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.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 following the implant of this transcatheter bioprosthetic valve, the two-hour electrocardiogram (ecg) showed left bundle branch block (lbbb) and a wide qrs rhythm.No treatment was reported.No adverse patient effects were reported.Eleven days following the valve implant the patient presented to the emergency department with substernal chest pressure/pain which radiated down the right arm.A computed tomography angiogram was negative for a pulmonary embolism.An electrocardiogram (ecg) revealed sinus rhythm with fusion complexes, interpolated premature ventricular contractions (pvc), with a left bundle branch block(lbbb) morphology.Troponin measured 0.17.A chest x-ray indicated sub-segmental atelectasis.An echocardiogram noted no significant abnormalities.The chest discomfort resolved.Intravenous therapy (iv) heparin was initially started and then discontinued.A non- st segment elevation myocardial infarction (nstemi) was reported which required hospitalization.The patient was discharged two days later and the nstemi was considered resolved.The physician had reported this event unrelated to the valve and unrelated to the procedure.Additional information was received which indicated that approximately 10 months and 15 days following the valve implant an ecg identified changes consistent with an incomplete right bundle branch block (rbbb).At approximately 11 months telemetry indicated a non-sustain ventricular tachycardia episode.The telemetry review noted this rhythm was more consistent with a lbbb which caused a wide qrs complex rather than non-sustained ventricular tachycardia.A repeat ecg showed an incomplete rbbb.A following ecg noted this had changed to a lbbb.The rbbb and lbbb rates were in the 70-90 beats per minute range.A transthoracic echocardiogram (tte) confirmed paravalvular leak (pvl) was not present with an ejection fraction of (b)(4)%.This prolonged an existing hospitalization.Further heart event monitor was to be performed following discharge.No adverse patient effects were reported during these episodes.Additional information was received which indicated that while hospitalized for an unspecified reason.Approximately one year following the valve implant, an ecg identified sinus tachycardia with first degree atrioventricular block.Cardiology was consulted.Paroxysmal atrial flutter/fibrillation with a rate dependent lbbb similar to previous admissions was identified.A prior 30-day heart monitor noted no high degree atrio-ventricular block which was consistent to this current presentation.The patient¿s metoprolol was increased to reduce the frequency and duration of the paroxysmal arrhythmia.Potassium was greater than 4 and magnesium greater than 2.Telemetry was continued and cardiology was considering anticoagulation.The physician reported this unrelated to the valve or valve procedure.No further treatment was reported.No additional adverse patient effects were reported.

• Brand Name: EVOLUT PRO PLUS 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: 15955265
• MDR Text Key: 305234835
• Report Number: 2025587-2022-03483
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000211127
• UDI-Public: 00763000211127
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: EVPROPLUS-29US
• Device Catalogue Number: EVPROPLUS-29US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Date Device Manufactured: 07/17/2020
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White