Citation: del trigo et al.Incidence, timing, and predictors of valve hemodynamic deterioration after transcatheter aortic valve replacement: multicenter registry.J am coll cardiol.2016 feb 16;67(6):644-655.Doi: 10.1016/j.Jacc.2015.10.097.Earliest date of publish used for event date.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 valve hemodynamic deterioration in a large cohort of patients undergoing transcatheter aortic valve replacement (tavr).All data were collected from multiple centers between may 2007 and october 2014.The study population included 1,521 patients (predominantly female, mean age 81 years), 756 of whom were implanted with medtronic corevalve (no serial numbers provided).Deaths occurred among patients implanted with medtronic and non-medtronic devices.However, based on the available information medtronic product was not directly associated with any of the death(s).Among all patients, adverse events included: valve hemodynamic deterioration (defined as greater than 10 mm hg increase in transprosthetic mean gradient between discharge and follow-up), high transvalvular mean gradients (greater than 40 mm hg in 8 patients), severe aortic regurgitation, severe prosthesis-patient mismatch, valve-in-valve implant, and additional tavr procedure.Based on the available information medtronic product may have been associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.
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