Medtronic received information from a literature article regarding the one-year outcomes in patients who underwent transcaval access tract closure with non-medtronic nitinol cardiac occluder devices following transcaval transcatheter aortic valve replacement (tavr).All data were collected from seventeen centers.The study population included 100 patients and was predominantly female with a mean age of 80 years.An unknown number of patients were implanted with medtronic evolut r transcatheter valves.No serial numbers were provided.One evolut r patient died due to a thoracoabdominal aortic dissection caused by the delivery catheter system crossing the aortic arch.Based on the available information, medtronic product was directly associated with the death.An additional 28 deaths occurred within one-year after transcaval tavr.Based on the available information, none of these deaths were attributed to medtronic product.Among all patients, adverse events included: covered stent implantation, iliac dissection requiring inferior vena cava filter placement or conservative treatment, aortic dissection, retroperitoneal hematoma, persistent fistula, major or life-threatening bleeding, blood transfusion, hospital admission for heart failure, and unspecified major adverse cardiovascular events within 30 days after transcaval tavr.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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