Medtronic received information that after an unknown time frame following the implant of this transcatheter bioprosthetic valve, it was reported that the right coronary cusp leaflet was "frozen".Unspecified aortic insufficiency and aortic stenosis was present.A mean gradient of 40 mmhg was reported.A replacement transcatheter valve was implanted, valve in valve.Following the implant of the replacement valve, it was reported that a post implant balloon aortic valvuloplasty (bav) was needed to fully expand the waist of the replacement valve.A post dilation was performed using a 22 mm non-medtronic balloon.No additional adverse patient effects were reported.
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Additional information was received which indicated that existing transcatheter valve had been implanted at 4 millimeter (mm) on both the non-coronary cusp (ncc) and the left coronary cusp (lcc).The reported aortic insufficiency was moderate central leak due to the coapt issue of a frozen leaflet.As reported, leaflet thickening of the initial transcatheter valve was possible.However, there was the inability to confirm via the computed tomography (ct) due to the artifact of the transcatheter frame.The previously reported gradient of 40 millimeters of mercury (mmhg) was the measurement of the pre-existing transcatheter valve before the replacement transcatheter valve was implanted.Following the implant of the replacement transcatheter valve the gradient measured 3 mmhg with the active valve.No additional adverse patient effects were reported.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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