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.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The baseline gender/age characteristics is male/65 years old.Of note, multiple patient s/multiple manufacturers/multiple methods were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers/manufacturer/method.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:¿post-ablation cerebral thromboembolisms in balloon-based ablation of atrial fibrillation with periprocedural direct oral anticoagulants: a comparison between cryoballoon and hot balloon ablation.¿ circulation.2018; 138(supplement 1).If information is provided in the future, a supplemental report will be issued.
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The literature publication reported the following patient complication during the use of a cryoballoon catheter: there were 20 patients who experienced ¿silent cerebral ischemic lesions.¿ there were also patients with bleeding complications with unknown treatment/resolution.Of note, multiple patients/multiple manufacturers/multiple methods were noted in the article; however, a one to one correlation could not be made with unique product lot numbers/manufacturer/method.The status/location of the cryoballoon catheter is unknown.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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