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MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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| Model Number EVPROPLUS-26 |
| Device Problems
Failure to Advance (2524); Device Dislodged or Dislocated (2923)
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| Patient Problems
Extravasation (1842); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Vascular Dissection (3160)
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| Event Date 08/31/2021 |
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Event Type
Death
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Manufacturer Narrative
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Concomitant medical products: other relevant device(s) are: product id: d -evprop23-29, serial/lot #: (b)(4), ubd: 03-jun-2022, udi#: (b)(4), product analysis: the valve remains implanted and the dcs was discarded, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve was implanted at good depth of 6 mm.As the pigtail catheter was being pulled from behind the frame out of the non-coronary cusp (ncc), the valve was pulled into the ascending aorta.A snare was placed on the paddle and the valve was pulled closer to the aortic arch.The second system was prepared.While advancing the capsule of the second delivery catheter system (dcs) through the first valve, it pushed the valve distal towards the sino tubular junction (stj).Resistance was met and multiple attempts were made to advance the capsule through the first valve without success.Patient became hypotensive and chest compressions were started.An angiogram of the aorta showed a perforation of the aortic wall with the inflow of the frame sticking out of the aorta with extravasation.The second valve was never deployed, it remained in the capsule.The patient expired.
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Manufacturer Narrative
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Additional information was received that the valve caused the perforation.The patient had moderate tortuosity in the femoral arteries and potential bicuspid anatomy based on slight dilation of the ascending aorta which was suspected to make the aortic wall more prone to disruption.It was reported that increased pressure may have been used during operation of the device.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.
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Manufacturer Narrative
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Additional information was received that according to the physician, the cause of death was the aortic dissection and perforation.An autopsy was performed.The autopsy findings indicated the same cause of death assessment as the physician.Updated b5.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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Manufacturer Narrative
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Conclusion: images of the implantation procedure or the implanted valve were not available for medtronic review.The valve and delivery catheter system (dcs) were not returned and therefore product analysis could not be performed.Review of the device history record (dhr) for the valve found it was built to specification and met all inspection and acceptance criteria.No issues were noted that would have impacted this event.A dhr review was performed on the dcs and there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.Potential factors that can influence a dislodged valve include tension applied on the dcs during positioning, calcification levels in the native vessel, compliance of the aorta and native vessels, and a number of others.In this case, it was reported that the valve was pulled into the ascending aorta as the pigtail catheter was being pulled out.However, a conclusive root cause could not be determined from the information available.Dislodge events are typically not related to a device malfunction.The valve was snared and pulled close to the aortic arch so a second valve could be implanted.Difficulties advancing the dcs is known to be related to procedural factors, user technique, and/or patient anatomy (angulation, cal cification, tortuosity, etc.).In this case, it was reported that the patient had moderate tortuosity in the femoral arteries and potential bicuspid anatomy.This indicates the probable cause of the advancement issues was patient anatomy.However, without procedural images and evidence available, an assignable root cause could not be determined and a relationship to the dcs cannot be established.Dislodgement of the valve by the distal tip is likely related to operator technique or experience; the evolut pro+ ifu, instructs ¿under fluoroscopic guidance, confirm that the catheter tip is coaxial with the inflow portion of the bioprosthesis¿ prior to drawing the dcs tip through the valve.With the information available and no images for review, the root cause of the dislodgement event could not be conclusively confirmed and a relationship to the dcs could not be established.Dislodgement events do not typically indicate a device malfunction or a failure to meet manufacturing specifications.Hypotension is a known potential adverse effect per the device ifu.It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally-functioning device or model implant procedure.With the information available, a conclusive cause could not be determined but the reported perforation was a likely contributing cause.Vascular injuries such as dissection and perforation, are known potential adverse patient effect per the evolut ifu, and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).In this case, a conclusive cause could not be determined from the information available.However, two things were reported that may have contributed to the perforation/dissection.The patient had potential bicuspid anatomy, which was suspected to make the aortic wall more prone to disruption.In addition, it was reported that increased pressure may have been used during operation of the device.The device ifu states ¿if there is a significant increase in resistance, stop advancement and investigate the cause of the resistance (for example, magnify the area of resistance) before proceeding.Do not force passage.Forcing passage could increase the risk of vascular complications (for example, vessel dissection or rupture).¿ chest compressions were started and a second valve was prepared for implant but the patient subsequently expired.An autopsy was performed and the cause of death was reported as aortic dissection and perforation.Patient death is a potential risk associated with the implantation of a bioprosthesis valve per the device ifu.A procedure- or valve-related death is an inherent risk when the patient condition is such that a transcatheter aortic valve is needed to sustain cardiac function, and it can occur despite an ideal implant procedure or device functionality.A conclusive relationship between the device and the death could not be established.Updated codes: h6 annex e method, result, conclusion codes.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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