Citation: madukauwa-david id et al.Might coronary flow influence transcatheter heart valve neo-sinus thrombosis? circ cardiovasc interv.2019 jul;12(7):e008005.Doi: 10.1161/circinterventions.119.008005.Epub 2019 jun 25.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 the 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 an analysis of multi-detector computed tomography data and benchtop experiments to investigate the influence of coronary flow on neo-sinus thrombosis in patients following transcatheter aortic valve replacement (tavr).All clinical patient data was retrospectively collected from the resolve registry subset of tavr patients without long-term anticoagulation therapy.The study population included 146 patients and was predominantly male with a mean age of 82 years.Of those, 94 were implanted with medtronic transcatheter bioprosthetic valves: corevalve, evolut r, or evolut pro.No serial numbers were provided.Among all patients, adverse events included: valve-in-valve implantation (5 cases).It was not reported whether these cases involved a second transcatheter valve being implanted in the initial transcatheter valve or a transcatheter valve being implanted in a degenerated existing surgical valve.Based on the available information, medtronic product may have been associated with the adverse events.Among all corevalve, evolut r, and evolut pro patients, adverse events included: hyperattenuated leaflet thickening/leaflet thrombosis (22 cases).It was noted that the left and right coronary cusp had smaller thrombus volumes than the non-coronary cusp.Based on the available information, medtronic product was associated with the adverse events.No treatment or intervention was reported as a result of the observed leaflet thrombosis.No additional adverse patient effects or product performance issues were reported.
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