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 65 years old.The baseline weight of the patients involved is 62 kgs.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: ¿feasibility of uninterrupted direct oral anticoagulants with temporary switching to dabigatran (¿dabigatran bridge¿) for catheter ablation of atrial fibrillation.¿ international heart journal.Released in advance online on j-stage november 15, 2019.Doi: 10.1536/ihj.19-143.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 the use of a cryoballoon ablation catheter: there was one patient with cardiac tamponade, (which was treated with pericardiocentesis); and one patient who had a stroke; this patient also experienced ¿memory impairment and disorientation¿ after the cardioversion procedure.There were also multiple patients who experienced ¿major¿ and ¿minor¿ bleeding events.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.The status/disposition of the cryoablation balloon 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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