MEDTRONIC IRELAND VALIANT CAPTIVIA - CW; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
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Model Number VAMF3232C200TE |
Device Problems
Malposition of Device (2616); Detachment of Device or Device Component (2907)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Device Embedded In Tissue or Plaque (3165)
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Event Date 07/13/2023 |
Event Type
Injury
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Manufacturer Narrative
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Film evaluation summary: the report tip detachment was confirmed on the films provided; however, the cause of the event could not be determined.The reported hemodynamic decompensation could not be assessed on the limited images available.Angiograms showing the device deployment and removal attempts, which would have helped to assess the exact moment when the tip detached, were not provided, limiting a more thorough assessment of the reported event.It is possible that the patient's tortuous thoracic aorta, may have been a contributory factor to the tip detachment, but this could not be confirmed.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 was implanted during the endovascular treatment of a 300mm thoracic dissection.It was reported the patient had a thoracic aortic aneurysm and while waiting for treatment, the aneurysm had ruptured and the patient was admitted emergently due to a type b dissection.It was reported that during the index procedure, the stent graft was deployed inthe descending aorta.During removal of the delivery system the taper tip got stuck with the freeflow stents at the greater curve and caused migration of the graft.There was a lot of resistance felt during the removal and after several attempts to retract the the tip, it detached from the delivery system and became lodged in the aortic wall.When trying to retrieve the tip the physician first tried to retrieve it using snaring technique while on the wire but this was not successful.After several attempts it was decided to leave behind.The tip stayed there between the graft and the subclavian artery and intervention was performed the following day where an open surgery to remove the tapered tip was performed.The patient became hemodynamically decompensated in the immediate post-operative period during the index procedure.The patient is cu rrently out of the icu, hemodynamically stable and in a favorable recovery from the last open surgery.Per the physician the cause of the event is undetermined.The patient anatomy was not noted to be very challenging however caution was needed due to the dissection at the descending aorta.No additional sequelae were reported and the patients will be monitored.
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Manufacturer Narrative
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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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