MEDTRONIC IRELAND ENDURANT ILIAC STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
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Model Number ENLW1624C95EE |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2023 |
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 have not 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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An endurant limb (enlw1624c95ee) was intended to be implanted during the treatment of a 57mm abdominal aortic aneurysm.It was reported during the index procedure, following the successful implantation of the main stent, the physician measured the length from the bifurcation of the main stent to the internal and external iliac bifurcation using roadmap mode on angiogram.According to the mapping catheter, the measurement was found to be 90+mm.The physician selected the (enlw1624c95ee) iliac stent and positioned it in the intended target location.Upon placement, it was discovered that the stent was too short and the distance from the bifurcation was 15mm.The device was withdrawn from the patient, and an alternative (enlw1624c120ee) iliac stent was selected for implantation.It was successfully implanted after pushing, and the internal iliac opening was not affected after the operation.It was unable to be determined whether the device was noted to have a different length than the one specified in the box or the vessel measu rement incorrect for the chosen device size.The cause of the dimensional deviation is not known per the physician.No additional clinical sequalae were provided and the patient is fine.
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Manufacturer Narrative
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Product analysis conclusions: the reported dimensional deviation could not be confirmed on the films provided, therefore, the cause of the event could not be determined.Angiograms showing the delivery system of the enlw1624c95ee in the left common iliac vessel was not seen, and only one viewpoint ( a-p) from the still angiograms was provided.The position of the delivery system and the radiopaque markers during implantation attempt is unknown.Analysis of the returned device did not reveal any out of specifications that could explain the reported event.The device returned with the external slider in the home position.The stent graft was positioned between the stent stop cup and the taper tip nose cone.There was no abnormalities evident to the device and stent graft.On deployment the distance between the stent stop cup and the taper tip nose cone was measured at 93mm.The deployed stent graft length was measured at 95mm.There was no abnormalities observed to the deployed stent graft.The reported dimensional deviation could not conclusively be determined.Ruler cal # 7367.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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