Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Of note, multiple patients/multiple methods/multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers/methods/manufacturers.The overall baseline gender characteristics is male; the age of the patients was 63 years old.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional in formation will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿current status and clinical outcomes of oral anticoagulant discontinuation after ablation for atrial fibrillation in japan findings from the af fron tier ablation registry.¿ circulation journal.Circ j 2019; 83: 2418 ¿ 2427 doi: 10.1253/circj.Cj-19-0602.If information is provided in the future, a supplemental report will be issued.
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The literature publication reported the following patient complications while using a cryoballoon ablation catheter: there were patients who experienced ¿major¿ bleeding events, strokes/tias, and/or ¿cardiovascular events¿ such as, myocardial infarction/unstable angina, hospitalizations for heart failure, and ¿other¿ cardiovascular events.The status of the catheter is unknown.Of note, multiple patients/multiple methods/multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers/manufacturers.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.
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