Model Number REL46 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Hematoma (1884)
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Event Date 07/22/2019 |
Event Type
Death
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Manufacturer Narrative
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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 iis stent graft system was implanted in a patient for the endovascular treatment of 55x70mm abdominal aortic aneurysm.It was reported that as the physician was ballooning the proximal neck with the reliant balloon, the physician felt as though the aorta ¿gave¿ while inflating the balloon.There was no issue noted at this point and final angio showed no issue.However, the patient complained of abdominal discomfort during recovery.A ct scan showed hematoma of the left kidney.The physician decided to bring the patient back into the or to explore the abdomen.There was some blood noted in the abdomen and the physician decided to place a cuff etcf2828c49e across the renal arteries to control bleeding.As per the physician, the cause of the event was due to a fragile aorta.No additional clinical sequelae were reported and the patient is fine.
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Manufacturer Narrative
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Additional information received; it was reported the patient expired.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 reported that the patient expired 8 days after the index procedure.As per the physician, the patient's death was related to the patient's fragile aorta and an error in inflating the reliant balloon too aggressively.The reliant balloon itself was not at fault.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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