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 characteristic is male.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.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: ¿an underrecognized complication of coronary artery spasm during cryoballoon guided atrial fibrillation ablation under deep sedation with dexmedetomidine.¿ european heart journal ( 2018 ) 39 ( supplement ), 411.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 a total of nine (9) patients who experienced coronary artery spasms during and after the ablation procedure.Two (2) patients also had st elevation during and after the procedure.There was also one (1) patient who had chest pain as well as st elevation, four (4) hours after the procedure.All patients were given nitroglycerin (ntg), with resolution of spasms.Two (2) patients had ¿late¿ coronary artery spasms; despite the administration of ntg; one of which was resolved with a bolus of ntg.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/location of the cryoablation 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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