MEDTRONIC HEART VALVES DIVISION OPEN PIVOT STANDARD AORTIC HEART VALVE; HEART-VALVE, MECHANICAL
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Model Number 500FA |
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); Unspecified Infection (1930); Myocardial Infarction (1969)
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Event Date 05/14/2022 |
Event Type
Injury
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Manufacturer Narrative
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Citation: vogt et al.Surgical aortic valve replacement in patients aged 50¿69 years: insights from the german aortic valve registry (gary).Eur j cardiothorac surg.2022 jun 15;62(1):ezac286.Doi: 10.1093/ejcts/ezac286.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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Medtronic received information via literature regarding surgical aortic valve replacement in patients aged 50 to 69 years. all data were collected from the german aortic valve registry between 2011 and 2012. the study population included 3,046 patients who were predominantly male with a mean age of 61.6 years. multiple manufacturer¿s devices were implanted in the study population; 537 patients were implanted with a medtronic hancock or mosaic (n=288) surgical valve or an ats open pivot mechanical valve (b)(4). no unique device identifier numbers were provided.Among all patients there were 42 in-hospital deaths (31 biological valve group, 11 mechanical valve group) and 335 long-term deaths (263 biological valve group, 72 mechanical valve group). no further details were provided on the deaths. there was no statement of causal or contributory relationship between medtronic product and the deaths.Among all patients, adverse events included: stroke, myocardial infarction (mi), new atrial fibrillation, arrhythmia requiring permanent pacemaker implant, bleeding, sepsis, and the need for reintervention. based on the available information medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.
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