This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is male/65 years old.The model listed in the report is a representative of the model family, as there is no specific model listed.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 was made.If additional information is obtained regarding this event, it will be added, and a supplemental report will be submitted accordingly.Referenced article: the long-term effect of thermal-guided second-generation cryoablation in paroxysmal and persistent atrial fibrillation.Indian pacing and electrophysiology journal 21 (2021) 261-266.Doi.Org/10.1016/j.Ipej.2021.05.002.If information is provided in the future, a supplemental report will be issued.
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A journal article was reviewed that contained information regarding cryoablation.The article reports patients who underwent cryoballoon ablation and experienced pericardial effusion requiring pericardiocentesis, transient ischemic attack (tia) or stroke, pseudoa neurysm of the superficial femoral artery, which required thrombin injection, aortic root perforation, and hematoma.No further patient complications have been reported as a result of this event.The status/disposition of the sheaths and catheters is unknown.Further follow up did not yield any additional information.
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