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Model Number 500FA |
Device Problem
Insufficient Information (3190)
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Patient Problems
Aortic Valve Stenosis (1717); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Hemorrhage/Bleeding (1888); Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 10/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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Citation: christ t, et al.Propensity matched long-term analysis of mechanical versus stentless aortic valve replacement in the younger patient.European journal of cardio-thoracic surgery.2021 jul 30;60(2):276-283.Doi: 10.1093/ejcts/ezab090.Presented at the 34th annual meeting of the european association for cardio-thoracic surgery, barcelona, spain, 8-10 october 2020.Earliest date of presentation 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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Medtronic received information from a literature article regarding a long-term analysis of mechanical versus stentless aortic valve replacement in the younger patients.All data was collected from a single center between 1993 and 2002.After excluding patients with congenital heart defects, aortic dissections, and ross-procedures, 158 patients with stentless valves and 226 patients with bileaflet mechanical valves were included in the study population (predominantly male, mean age 52 years).In the stentless aortic valve replacement (savr) group, 152 patients received a non-medtronic valve and 6 received a medtronic freestyle valve.In the mechanical aortic valve replacement (mavr) group, 187 patients received a non-medtronic valve and 39 received a medtronic open pivot valve.No unique device identifier numbers were provided.Among all 348 patients in the study population, actuarial long-term survival20 years after aortic valve replacement was a mean 47.0% in the savr group and a mean 53.3% in the mavr group.No statement was made suggesting a causal or contributory relationship between medtronic product and the deaths.Among all 348 patients in the study population, non-death adverse events that occurred following aortic valve replacement included: major bleeding, peri-procedural stroke, need for permanent pacemaker implantation, and reoperation.In the savr group, reasons for reoperation consisted of aortic insufficiency, aortic stenosis, and endocarditis.In the mavr group, reasons for reoperation consisted of insufficiency, endocarditis, stenosis, and unknown causes.No additional adverse patient effects or product performance issues were reported.
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Search Alerts/Recalls
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