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.Patient information is limited due to confidentiality concerns.Of note, multiple patients/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with manufacturers/methods/unique lot numbers/adverse events.The model listed in the report is a representative of the model family, as there is no specific model listed.The baseline gender/age of the patients represented in the article is male/74 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 information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿uninterrupted direct oral anticoagulant and warfarin administration in elderly patients undergoing catheter ablation for atrial fibrillation a comparison with younger patients.¿ j am coll cardiol ep 2018;4:592¿600.Https://doi.Org/10.1016/j.Jacep.2018.02.013.If information is provided in the future, a supplemental report will be issued.
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The literature publication reports the following possible patient complications while using a cryoablation balloon: there were patients with cerebral infarctions, transient ischemic attack (tia), cardiac tamponade, arteriovenous fistula requiring surgery, bleeding hematoma requiring blood transfusion, pericardial effusion requiring blood transfusion, puncture site bleeding or hematoma, pericardial effusion without tamponade, and arteriovenous fistulas without intervention.There was medical/surgical intervention taken for many of the adverse events there were also two patients each with "continuous bloody phlegm," and "continuous hematuria;" there was no indication of treatment/resolution for these two patients.Of note, multiple patients/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with unique manufacturer/product serial numbers/adverse events.Further follow up did not yet yield any additional information.The status/location of the cryoballoon is unknown.No further patient complications have been reported as a result of this event.
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