MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTR-34-C |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Atrial Fibrillation (1729); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)
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Event Date 04/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the device remains implanted and no procedural images were submitted for review; therefore, no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made 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.
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Event Description
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Medtronic received information that two days following the implant of this transcatheter bioprosthetic valve, an episode of asymptomatic non-sustained ventricular tachycardia (nsvt) was identified after the temporary pacemaker was interrogated with 0% pacing.Medication was not restarted due to first degree atrio-ventricular (av) block.No treatment was reported, and the event resolved on the date of onset.No adverse patient effects were reported.Additional information was received that after the valve implant an echocardiogram indicated trace paravalvular leak (pvl).Hypotension was also noted and was treated with medication.The hypotension resolved one day post implant.No treatment was prescribed for the pvl.No adverse patient effects were reported.Additional information was received that the patient was diagnosed with chronic systolic and diastolic heart failure with new york heart association functional classification: iii.It was noted the patient was not in acute exacerbation.One day following valve implant, an echocardiogram showed the left ventricular ejection fraction (lvef) was severely decreased, estimated at 20-25%.Global hypokinesis was also noted.Twenty-two days following valve implant an echocardiogram showed the lvef remained at 20-25%.It was noted the patient has chronic severe non-ischemic cardiomyopathy with a baseline ejection fraction (ef) of 25%.At the two-year post-operative appointment, transthoracic echocardiogram showed an ef of 28%.Approximately three years, four months following valve implant, the patient presented to the emergency department with reported complaint of worsening shortness of breath over the past few weeks.The patient denied chest pain.Upon assessment the patient was in atrial fibrillation with rapid ventricular response.Medication was administered.Upon diagnostic assessment, an echocardiogram was performed and showed an ejection fraction of 15%, a decrease from 45%.Electrical cardioversion was performed with success.Further adjustments were made to prescribed medications.Three days later the patient was reported to be recovered.Per the physician, the relation between the medtronic valve and the adverse event was unl ikely.No adverse patient effects were reported.
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Search Alerts/Recalls
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