Concomitant medical products: arctic front advance cardiac cryoablation catheter 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.Patient information is limited due to confidentiality concerns.Of note, multiple patients 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.The age range for the patients was a group less than 75 years old and a group older that 75 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.The cause and date of death is not available at the time of this report; as there is no indication of specific lot number for patient information.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿efficacy and safety of cryoballoon ablation for chinese patients over 75 years old: a comparison with a younger cohort.¿ journal of cardiovascular electrophysiology.2019; 10.1111/jce.14220.If information is provided in the future, a supplemental report will be issued.
|
The literature publication reported the following patient complication during the use of a cryoballoon ablation system: there was mention of two patient deaths; however, there is no indication as to the specific cause of death and/or death-device/procedure relatedness.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 catheter system is unknown.Further follow up did not yet yield any additional information.
|