Citation: tavilla g.; et al.Redo surgical aortic valve replacement for prosthetic valve valve-in-valve dysfunction.J card surg.2022 apr;37(4):1098-1100.Doi: 10.1111/jocs.16260.Pmid: 35060201.Epub 2022 jan 20.Earliest date of publication used for date of event.Medtronic products referenced: evolut (pma# p130021, product code: npt).Earliest approved product used for product code and pma#.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.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information via literature regarding a (b)(6)-year-old female patient with atrial fibrillation, hypertension, coronary artery disease and diabetes mellitus who underwent coronary artery bypass grafting (cabg) and concomitant surgical aortic valve replacement (savr) approximately nine years earlier.Five years after replacement, the patient became symptomatic from severe prosthetic stenosis.The patient then underwent valve-in-valve transcatheter aortic valve replacement (viv tavr) using a 23-mm medtronic evolut bioprosthetic valve (unique device identifier number not provided).It was noted the patient¿s symptoms never improved, but only worsened with severe fatigue and shortness of breath with daily activities over the next three years.Echocardiography after hospitalization showed moderate central aortic regurgitation.The patient underwent surgical valve removal and replacement with a non-medtronic bioprosthetic valve.It was noted the evolut valve stent had partially incorporated into the aortic neointima layer with adhesions.Microscopic examination after explant noted the valve leaflets containing fibroconnective tissue with micro-calcifications.No additional adverse patient effects or product performance issues were reported.
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