MEDTRONIC IRELAND ENDURANT II ILIAC STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
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Model Number ETLW1616C146E |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2022 |
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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An endurant ii limb was intended to be implanted for the endovascular treatment of a 60mm abdominal aortic aneurysm. it was reported once the graft was opened a human hair was noted sticking out and wedged into the deployment system.It is stated the hair could not have been from anyone in the room as it was noticed before the scrub tech received the graft and the hair was wedged into the end of the deployment system.It is suspected the hair came from the manufacturing facility. the attending sales representative pulled out the hair after it was decided the device couldn't be used and the hair broke in two pieces, one remained jammed in the deployment system, the device was then discarded.As per the physician the cause cannot be determined. no additional clinical sequalae was provided and the patient is fine.
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Manufacturer Narrative
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Device evaluation summary: 8 still images were received for analysis.Images 1-7 depict the rear handle and back-end t-tube of an endurant device in a shipping tray.A fiber can be seen stretched between the t-tube and the shipping tray.In image 7 the fiber appears to have broken in half as a result of attempts to remove the device from the shipping tray.Image 8 depicts an endurant peel-off label attached to a form.Lot number and device details on the label match that reported on gch.Images confirm the presence of a foreign fiber on the device, however the exact nature or origin of the fiber cannot be confirmed from the images provided.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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