MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 995 |
Device Problems
Calcified (1077); Material Deformation (2976); Material Split, Cut or Torn (4008)
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Patient Problems
Atrial Fibrillation (1729); Calcium Deposits/Calcification (1758); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Pulmonary Valve Stenosis (2024); Cusp Tear (2656); Heart Block (4444); Pulmonary Valve Insufficiency/ Regurgitation (4452)
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Event Date 03/01/2023 |
Event Type
Injury
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Event Description
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Literature was reviewed regarding interventional versus surgical treatment of degenerated freestyle prostheses.The study population included 56 patients who were predominantly male with a mean age of 70.6 years.Of these patients, all were implanted with a medtronic freestyle surgical bioprosthetic conduit.Among all patients adverse events included: pulmonary regurgitation, stenosis, calcification, leaflet tear, dilatation, endocarditis, stroke, myocardial infarction, major bleeding or vascular complication, renal failure, atrial fibrillation or atrio-ventricular (av) block or other arrhythmia requiring permanent pacemaker implant.No additional adverse patient effects were noted.
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Manufacturer Narrative
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Citation: fedorov et al.Interventional versus surgical treatment of degenerated freestyle prosthesis.Thorac cardiovasc surg.2023 mar 1.Doi: 10.1055/s-0043-1763286.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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.If information is provided in the future, a supplemental report will be issued.
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