MEDTRONIC HEART VALVES DIVISION HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number T505 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Atrial Fibrillation (1729); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Thromboembolism (2654); Thrombosis/Thrombus (4440); Heart Block (4444)
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Event Date 10/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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Citation: veres et al.Long-term outcomes stratified by age in patients with a mechanical versus biological mitral valve replacement.J cardiovasc dev dis.2022 oct 6;9(10):339.Doi: 10.3390/jcdd9100339.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.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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Literature was reviewed comparing long-term outcomes of bioprosthetic versus mechanical mitral valve replacements.The study population included 2056 patients who were predominantly male with a mean age of 65.4 years.Patients implanted with a medtronic product received a mosaic or hancock ii bioprosthetic valve or hall mechanical valve.Among all patients adverse events included: myocardial infarction, arrhythmia requiring permanent pacemaker implant, embolism or thrombus, bleeding, stroke, atrio-ventricular (av) block, and atrial fibrillation.No additional adverse patient effects were reported.
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