MEDTRONIC IRELAND ENDURANT IIS BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Model Number ESBF2514C103E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Anemia (1706); Hemorrhage/Bleeding (1888)
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Event Date 03/15/2024 |
Event Type
Injury
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Event Description
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An endurant iis stent graft system was implanted as part of the advance study for the treatment of an abdominal aortic aneurysm.It was reported during the index procedure, the patient experienced high intraoperative blood loss attributed to the failure of the non mdt percutaneous closure device.The non-mdt device failed on the left side.An additional two closure devices were placed which seemed to show hemostasis.The wire of the device was then pulled and pressure held, but bleeding continued.An artery cut down and open repair was preformed, which led to elevated blood loss due to the patient's habitus and fragile tissues.As a result of the complications, the patient required prolonged existing hospitalization from (b)(6) 2024, to (b)(6) 2024.The site assessed the intraoperative blood loss as having a causal relationship to the index procedure and not device related or related to underlying patient condition.The sponsor assessed the the intraoperative blood loss as having a causal relationship to the index procedure and not device related or related to underlying patient condition.No additional clinical sequalae were provided and the patient is fine.
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Manufacturer Narrative
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Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: e tlw1620c93e, serial/lot #: (b)(6), ubd: 31-mar-2024, udi#: (b)(4); product id: etlw1620c93e, serial/lot #: (b)(6), ubd: 05-sep-2024, udi#: (b)(4).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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B5; additional information received : it was reported the estimated blood loss (ebl) was 1500mls.The patients hb was 10.9 g/dl on the day of the procedure and decreased to 8.7 g/dl two days later.No blood transfusion was required.During the procedure, a interposition bypass graft from distal external iliac artery onto the profunda femoral artery with re implantation of the sfa using a 8mm non mdt prosthetic graft.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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