MEDTRONIC IRELAND VALIANT CAPTIVIA - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Model Number VAMF2626C150TE |
Device Problems
Defective Component (2292); Malposition of Device (2616); Material Deformation (2976)
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Patient Problem
Vascular Dissection (3160)
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Event Date 01/22/2024 |
Event Type
Injury
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Manufacturer Narrative
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Device evaluation summary: an image capturing deformation of the graft cover was received.The graft cover material was twisted and raised.A gap was visible between the taper tip and graft cover tip.The reported deformation in vivo was confirmed through image review.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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Event Description
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A valiant captivia stent graft (vamf2626c150te) was implanted to treat a 45mm thoracic aortic aneurysm.It was reported during the index procedure, that when the valiant captivia stent graft was deployed, it was observed under fluoroscopy that the stent graft had shifted posteriorly from the intended location.When it moved the left subclavian was not blocked, but when the stent was deployed posteriorly initially it pressed against the subclavian artery.The graft was repositioned in the planned position without any obvious endoleak however a dissection under the left subclavian was observed that was not seen on angio before deployment.Upon attempting to withdraw the delivery system, it was found that the outer sheath and bare stent could not be closed at the tip head, preventing the withdrawal of the stent from the aortic isthmus. despite multiple attempts , the delivery system handpieces were eventually closed, except for the top. access was re-established through the contralateral femoral artery where a snare and a ab46 balloon were used to successfully grip onto the tip of the delivery system, allowing for its successful withdrawal.On removal the membrane covering on the distal end of the stent graft cover was suspected to be damaged.It was noted the physician used force during this maneuver.The dissection remained untreated. per the physician the cause of stent movement, dissection and gap at the tip are undetermined but noted that there was no vessel thrombus or calcification that may have led to the damage to the graft cover.No additional clinical sequelae were provided, and the patient will be monitored.
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Manufacturer Narrative
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Film analysis the reported inaccurate delivery, dissection of the thoracic aorta and gap between the taper tip and graft cover tip could not be confirmed from the limited films provided.Procedural angiogram videos showing the deployment of the stent graft and removal of the delivery system were not available for a thorough assessment of the reported events.Post-implant cts could allow for a more thorough assessment of the stent graft in-vivo configuration and dissection.It is possible that the severe tortuosity of the distal aortic arch was a contributory factor in the reported movement of the stent graft from the intended location.Analysis of the returned films did not reveal any obvious stent graft integrity issues.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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