Citation: kadan m, et al.Early- and mid-term results of cryoablation of atrial fibrillation concomitant with robotic mitral valve surgery.Anatol j cardiol.2021 apr;25(4):266-272.Doi: 10.14744/anatoljcardiol.2020.81669.Earliest date of publish used for date of event.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 early and mid-term results of cryoablation for atrial fibrillation (afib) concomitant with robotic mitral valve surgery.All data were retrospectively collected from a single center between 2014 and 2020.The study population included 34 patients (predominantly female, mean age 58 years), all of whom were implanted with either a medtronic open pivot mechanical heart valve, hancock bioprosthetic valve, profile 3d or contour 3d annuloplasty ring.Serial numbers were not provided.Among all patients, two deaths occurred due to low cardiac output syndrome and hepatorenal syndrome and were not attributed to a medtronic device among all patients, adverse events included: first degree heart block, new onset atrial fibrillation (afib) and complete heart block (chb) treated with permanent pacemaker, left ventricle rupture treated with a sternotomy and myocardial ischemia treated with the implant of a stent.Based on the available information, a 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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