Medtronic received information from a literature article regarding an evaluation of whether protamine administration for heparin reversal after transcatheter aortic valve replacement (tavr) affects bleeding complications and patient outcomes.All data were collected from a single center between february 2013 and may 2018.The study population included 873 patients and was predominantly female with a mean age of 81 years.Of those, 343 were implanted with medtronic evolut r or evolut pro transcatheter valves.No serial numbers were provided.Among all patients, 90 all-cause deaths occurred within one-year after tavr.Further details were provided for three of the deaths: one patient died due to hemorrhagic shock caused by massive intra-abdominal bleeding, and two patients died due to retroperitoneal bleeding at the access site.Multiple manufacturers transcatheter valve systems were involved in the study and the identities of the valve systems that were used to treat these patients was not reported.Based on the available information, medtronic product was not directly associated with the deaths.Among all patients, access site and access-related vascular injuries were observed and were classified into four types: type i, blush or minimal extravasation; type ii, moderate extravasation (less than 5 mm); type iii, major extravasation (greater than 5 mm) including vessel perforation or rupture; and type iv, vessel dissection or occlusion.Treatment included: manual compression with application of a pressure bandage (types i and ii), percutaneous transluminal angioplasty (types iii and iv), or covered stent graft implantation (types iii and iv).Additional adverse events that were observed: life-threatening or major bleeding, major vascular complications, blood transfusion, conversion to open heart surgery, stroke, myocardial infarction due to procedure-related thrombotic occlusion of the right coronary artery, and acute myocardial infarction due to a left coronary artery obstruction related to the implanted valve.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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