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.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 prior to the implant of this transcatheter bioprosthetic valve, the patient was sized for a 29 mm valve.During a pre-implant balloon aortic valvuloplasty (bav) with a 22 mm balloon, the patient's native valve was damaged and severe aortic regurgitation (ar) followed.The valve was partially deployed to 85% while in two cusp view showing it positioned around 2 mm on the non-coronary cusp (ncc) side.In the left anterior oblique (lao) view revealed that the valve was closer to 0 or -1 on the left coronary cusp (lcc) and deemed too high.The valve was recaptured and pulled into the ascending aorta while an attempt was made to bring the patient back into sinus rhythm.Despite the unsuccessful attempts to return to sinus rhythm, it was decided to deploy the valve.During the second deployment, the valve was positioned between 3-5 mm on both the ncc and lcc.The patient had been receiving cardiopulmonary resuscitation (cpr) for about 15 minutes and was continued as sinus rhythm could not be restored.After another round of 15 minutes of cpr and using a mechanical device and not being able to restore the patient to sinus rhythm, the physician decided to post dilate the valve to remove the moderate paravalvular leak (pvl).During the dilation, the balloon ruptured and dragged the valve into the ascending aorta.An non-medtronic valve (edwards 26 mm) was then implanted.However, the patient died shortly after.Following the procedure, the physician acknowledged that this was an extremely high risk patient with low blood pressure, a classic type zero bicuspid valve, poor cardiac condition and had been refused cardiac surgery.Per the physician, the patient's underlying conditions contributed to the patient not being able to recover from the severe aortic regurgitation following the initial pre-implant bav procedure and there was no allegations of deficiency against the valve.The cause of death was not reported.Additional information was received from the physician which reported functional conduction disturbance occurred, immediately after the pre-implant bav which had caused acute and severe ar.According to the physician, the cause of death was acute left ventricular failure.
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Conclusion: the valve remained implanted, therefore no product analysis could be performed.Review of the returned images showed two images of the pre implant balloon aortic valvuloplasty (bav).The images showed unstable balloon inflation.One image showed the lumbar arteries filling with contrast from the descending thoracic aorta, which would be indictive to a conduction disturbance.The additional image showed the left coronary artery filling, however the contrast did not wash out as it would in a normal cardiac cycle.No hemodynamic information was made available in the returned images.Another image showed the medtronic valve at 80% deployment with contrast extravasation.It was difficult to determine where the contrast was going in this view, however, it appeared to be a mediastinum hematoma.It is likely that this mediastinum hematoma occurred as a result of the reported pre dilatation that was performed prior to the mdt valve being deployed.An additional image showed a contrast injection in the ascending aorta with the medtronic valve retracted from view.It is difficult to view, however, there is contrast extravasation into the free wall.The subsequent image showed the valve fully released sitting at 0 mm, -1 mm on the non-coronary cusp (ncc) and 4-5 mm on the left coronary cusp (lcc) with a significant amount of space.This would suggest under sizing.The patient summary and raw computed tomography (ct) images were unavailable for review.Within the cine film, at the inflow of the medtronic bioprosthetic valve, there appears to be something that is ¿flailing around¿, which may be indictive to a cusp dissection, on the damaged native valve.The final image showed a ¿dog boning¿, in the post dilation right before the balloon ruptures.The ¿dog boning¿ of the bav indicated that there was something going on within the patient anatomy to create a waist area in the balloon.Imaging of the non-medtronic valve placement was not provided.Paravalvular leak (pvl) can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.The user followed the instructions in the instructions for use, (ifu) by performing a post implant balloon aortic valvuloplasty, (bav), however it is unknown what inflation pressure, or type and size of balloon used.The instructions in the ifu state; in the event that valve function or sealing is impaired due to excessive calcification or incomplete expansion, a postimplant balloon dilatation of the bioprosthesis may improve function and sealing.If the heart team determines that a balloon dilatation is appropriate, consider all of the following factors when selecting the dilatation parameters to ensure patient safety: balloon model, size, position, inflation pressure and patient anatomy must be considered when selecting the size of the balloon used for dilatation.The balloon size chosen for dilatation should not exceed the diameter of the native aortic annulus.The returned images for this post bav show significant amount of space around the valve that might suggest under sizing of the valve, however, this is unable to be confirmed without reviewing patient case plans.The bav also displayed a "dog boned" shape, right before the balloon r uptured.During the dilation, the balloon reportedly ruptured and dislodged the valve into the ascending aorta.Potential factors that can influence a dislodged valve include tension applied on the delivery catheter system, (dcs) during positioning, calcification levels in the native vessel, inadequate deployment due to improper sizing between valve and annulus, irregular patient anatomy, or incomplete frame expansion.The significant space viewed around the valve on the fluoroscopic images may have played a role in the valve dislodging into the ascending aorta after the bav ruptured.Dislodge events are typically not related to a device malfunction.Per the event description and information provided, the dislodgement event is assessed as related to the device and was due to the post implant bav, which was performed.The physician acknowledged that this was an extremely high-risk patient with low blood pressure, a classic type zero bicuspid valve, poor cardiac condition and the patient had been refused cardiac surgery.Additionally, the physician stated that the patients underlying conditions contributed to the patient not being able to recover from the severe aortic regurgitation following the initial pre- implant bav procedure, and that there were no allegations of deficiency against the evolut pro valve.In summary, the pre implant bav that had been performed prior to the evolut pro implant, most likely caused damage to the patient¿s native valve causing a conduction disturbance, which was confirmed by the physician, that occurred immediately after the pre-implant bav which then led to acute and severe aortic regurgitation.Per the event description and information provided, the dislodgement event is assessed as related to the device and was due to the reported post implant bav.Per the physician, the cause of death was acute left ventricular failure, and the patients¿ underlying conductions contributed to the patient not being able to recover from the severe aortic regurgitation following the pre implant bav.The physician also stated that there was no allegation of deficiency against the evolut pro valve.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.This event does not indicate device misuse or malfunction.Updated h6.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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