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.Of note, multiple patients/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.The overall baseline gender characteristics is males; the age of the patients was 60 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: ¿temporal trends in safety and complication rates of catheter ablation for atrial fibrillation.¿ journal of cardiovascular electrophysiology.2018; 29(6):854-860.Doi: 10.1111/jce.13484.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 during an ablation procedure using a cryoballoon ablation catheter: there were patients who experienced atrioesophageal fistulas, vascular hematoma, pseudoaneurysm, bleeding, atrioventricular block, aspiration pneumonia, perforation/tamponade, phrenic nerve paralysis, embolic stroke, and pulmonary vein stenosis.Treatment included drainage,and/or surgical repair.Of note, multiple patients/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.The status/location of the 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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