Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information that during implant of this transcatheter bioprosthetic valve, into a patient with type 0 bicuspid sievers valve with stenosis and aortic tortuosity, the valve was loaded successfully.A pre-balloon aortic valvuloplasty (bav) was performed with a 20 millimeter (mm) balloon.The balloon had to be positioned twice for optimization.The delivery catheter system (dcs) was advanced over the aortic arch with some resistance however tracking appeared reasonable to advance and position into the ascending aorta just superior to the annulus.The valve was advanced to the annulus with an attempt to cross however resistance was met as the nose cone was trying to negotiate a mild/moderate turning course at the annulus without tracking success and created tension in the catheter.Multiple forward attempts were made without success.The valve was withdrawn from the annulus and back across the aortic arch.The valve was positioned into the descending aorta and fluoroscopy visually inspected the valve and nose cone which appeared normal.The patient remained stable.The dcs was rotated 90 degrees and re-advanced.Multiple forward attempts were made again w without success.It was determined to abort the case.The patient remained hemodynamically stable.The valve and dcs were withdrawn into the superior ascending aorta while optimally managing the stiff wire position in the left ventricle when the arch abruptly moved and changed its position taking the dcs it the movement.The valve was withdrawn to the descending aorta in preparation for removal.The patient became hemodynamically unstable with no pulse pressure and chest compressions were initiated.An ultrasound echocardiogram was performed quickly to determine a pericardial effusion however imaging was sub-optimal.Cardiopulmonary resuscitation (cpr) persisted for up to 20 minutes in preparation for surgical conversion however the patient died.Per the physician, the cause of death was an aortic perforation near the superior ascending aorta/arch transition area.It was noted that the patient had thin vessel tissue.
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