MEDTRONIC IRELAND VALIANT CAPTIVIA - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Model Number VAMF3434C200TE |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2024 |
Event Type
malfunction
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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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Event Description
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A valiant captivia stent graft (vamf3434c200te) was implanted during the endovascular treatment of an 70mm thoracic aortic aneurysm.It was reported during the index procedure, a gap was observed the tip at the top of the stent and the proximal outer sheath could not be fully closed.Although the physician had concerns of the high possibility of causing damage to blood vessels the graft was used.Slight difficulty was encountered when advancing the graft but it was delivered successfully and valiant captivia stent opened normally and was deployed successfully isolating the taa.Per the physician the cause of the tip issue was due to a device problem.No additional clinical sequelae were reported, and the patient is fine.
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Manufacturer Narrative
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Product analysis conclusion :a series of three (3) images and an eight (8) second video clip were received.One of the images captures a gap between the graft cover and taper tip prior to use of the device.It was not possible to determine the length of the gap from the images.A gap is again visible post deployment of the stent graft despite the external slider and tip capture release mechanism being in the home position.The reported dimensional deviation was confirmed through image review.Additional information received: it was confirmed the box was sealed when taken off the shelf.There was no damage to packaging.The gap was noted when the devices box was opened before it came into contact with the patient.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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