Medtronic received information via literature regarding an 86-year-old male patient with severe aortic stenosis who underwent implant of a medtronic evolut pro+ bioprosthetic valve (unique device identifier numbers not provided).Following successful placement and expansion of the valve there was an ¿acceptable range of paravalvular leak¿.However, calcification was found to be partially separated and dangling in the left ventricle (lv).The heart team decided to remove the calcification.Via sternotomy and a 2-cm incision on the ascending aorta, an endoscope and forceps were inserted through the deployed transcatheter valve.The delaminated calcified nodule was successfully extracted without any loss of function of the transcatheter valve.The patient was discharged without adverse events on postoperative day 19.No additional adverse patient effects or product performance issues were reported.
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Citation: funaki et al.Successful removal of delaminated left ventricular outflow tract calcification during transcatheter aortic v alve replacement.Cardiovasc interv ther.2022 apr;37(2):420-421.Doi: 10.1007/s12928-021-00791-6.Epub 2021 jun 21.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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