The device remains implanted, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure (open or catheter-based) and can be resolved with medical treatment or the implant of a permanent pacemaker (with the risk-benefit ratio in favor of implant of the percutaneous aortic valve).A conduction disturbance does not indicate a device malfunction or potential manufacturing issue.Please be informed that this information is collected via the (b)(6) registry.This prospective, multicenter registry captures implant and follow up data of patients with severe and symptomatic bicuspid aortic valve stenosis.Medtronic is not the owner of the data and does not have access to information that has not entered into the (b)(6) registry database.If additional information is received, it will be provided in a supplemental report.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information from the (b)(6) registry that during the implant of this transcatheter bioprosthetic valve into a patient with a bicuspid aortic valve, an electrocardiogram (ecg) indicated a left bundle branch block (lbbb).Subsequently, a defibrillator was implanted.No additional adverse patient effects were reported.No further information was provided.
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