MEDTRONIC IRELAND VALIANT CAPTIVIA - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Model Number VAMF3030C200TE |
Device Problems
Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2024 |
Event Type
malfunction
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Event Description
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Valiant captivia stent graft was implanted during the endovascular treatment of a thoracic aortic ulcer.It was reported during the index procedure, after the three most proximal stent rings were deployed and when attempting to quickly deploy the rest of the stent graft past the aortic arch, deployment difficulties were encountered.It was found that the trigger could not be pressed and it was not possible to deploy the stent by pulling back the trigger to engage the quick-release function of the delivery system.The physician resolved the deployment issue by slowly turning the handpiece to deploy the stent graft.During removal of the delivery system, it was not possible to pull the tapered tip back into the graft outer sheath of the delivery system by pressing the trigger to pull back the slide.The device was removed by slowly turning the handpiece.It was reported that the ifu was followed and there was no damage noted to the delivery system or device packaging during unboxing.There was no vessel thrombus, calcification or tortuosity that may have contributed to the resistance problems.Per the physician the cause of the deployment and removal difficulties was not determined.No additional clinical sequelae were provided, and the patient is fine.
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Manufacturer Narrative
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Film evaluation summary: the reported deployment and removal difficulties events could not be confirmed on the pre-implant report available, therefore, the cause of the event could not be determined.Lack of complete pre-implant cts did not allow for a more thorough assessment of the pre-implant anatomy.Angiogram videos showing the deployment of the device were not available for review.It is possible that the observed anatomical characteristics such as the presence of thrombus and a highly angulated aortic arch may have contributed to the deployment difficulties, 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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Manufacturer Narrative
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Product analysis the delivery system returned with the external slider and the tip capture release mechanism in the home position.Two slight kinks were visible on the graft cover.The taper tip was deformed.The graft cover was advanced and retracted using the release trigger with no difficulties noted.The screw gear threads confirmed there was no deformation which could have hindered advancement and retraction of the slider.The external slider was disassembled, and the internal slider removed.When retracted the spring returned to the home position when released following each activation with no evidence of the spring hanging up on the internal slider tooth.The spring retainer and the spring were removed.On inspection of the spring a small burr was observed on one end.A longitudinal scratch was visible on the internal sider.When reassembled the burr on the spring was positioned at the location of the scratch on the internal slider.The reported deployment/expansion issue and removal difficulties were not confirmed through analysis.Deformation in-vivo was confirmed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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