MEDTRONIC IRELAND ENDURANT II AUI STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Model Number ETUF2814C102EJ |
Device Problems
Difficult to Insert (1316); Positioning Problem (3009)
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Patient Problems
Perforation of Vessels (2135); Rupture (2208)
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Event Date 12/21/2023 |
Event Type
Injury
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Event Description
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An endurant ii aui stent graft was implanted during the endovascular treatment of 48mm aaa.It was noted that the diameter of the aorta near the renal artery was 21mm, the proximal neck length was 29mm.There was no vessel tortuosity and there was a general abundance of calcification.It was reported that during the index procedure , the calcification was strong overall and the external iliac artery blood vessel diameter was 5mm.An 8 mm pta balloon was used before device insertion to widen the blood vessel however, the calcification was strong and 2 pta balloons were torn.Afterwards, a non mdt sheath 12f inner cylinder was inserted and the 12f main unit was inserted followed by the dry seal 14f inner cylinder insertion and 14f main unit insertion and lastly the dry seal 16f inner cylinder insertion and 16f main unit insertion.Afterwards, it was attempted to insert the endurant, but the delivery system failed to pass the eia.It was removed and the 14f dry seal was replaced.Around 2 minutes later, the blood pressure rapidly decreased to 45/22, so a rupture was suspected.Balloon occlusion was performed and angiogram was performed to check the eia rupture.Afterwards a non-mdt stent was placed.The endurant was then inserted after the condition was good, and the procedure was completed successfully.Per the physician the cause of the insertion difficulties was related to the patient's anatomy due to the patient's poor characteristics in the diameter of the access blood vessel and the narrow blood vessel.It was suspected that the condition of the blood vessel might have been worse than from the time of pre-operative imaging.No additional sequelae were reported and the patients is fine.
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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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Manufacturer Narrative
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Additional information received: it was clarified that it was difficult to position the delivery system through the vessel, and not through the non-medtronic sheaths.Since there was a possibility that it would be difficult to pass the access, non-medtronic sheaths (inner diameter 12f, 14f, 16f) were used as a dummy sheath.The dummy sheath was removed and the physician tried to introduce the delivery system without the sheath.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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