MEDTRONIC IRELAND ENDURANT II BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
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Model Number ETBF2313C124EJ |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis conclusion: one (1) image of a pouch was received from the account.There is no label present on the pouch to identify product customer facing number or serial number.The reported device marking issue was confirmed through the image review.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 stent graft etbf2313c124ej was implanted during the endovascular treatment of an 50mm abdominal aortic aneurysm.It was reported during the index procedure, when unboxing the device, the seal with lot and serial numbers were missing from the device's packaging.The device's size was verified using the seal on the delivery system, and the device was successfully implanted, and treatment was complete.Per the physician the cause of the device marking issue was not attributed to physician.No additional clinical sequelae were provided, and the patient is fine.
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Search Alerts/Recalls
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