The lot number was not provided.Therefore the udi is not available.The review of the manufacturing paperwork could not be performed as the lot number(s) were not available.The gore® tri-lobe balloon catheter instructions for use state ¿do not inflate the balloons in areas of significant calcified plaque.Balloon rupture and / or vessel damage may occur¿.Additionally the ifu states, adverse events which may require intervention include, but are not limited to: rupture and death.
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On (b)(6) 2018, the patient underwent treatment of a thoracic aortic aneurysm with a medtronic endoprosthesis and gore® tri-lobe balloon catheter.It was reported the device was implanted distal to the left subclavian artery (lsa).Reportedly, deployment of the device was successful as the device landed in its intended location.It was reported the physician inflated a gore® tri-lobe balloon catheter completely within device for post implantation ballooning.It was reported the patient had extreme calcification in the landing zone of the device.It was also reported the aortic neck was short (length unknown).It was reported immediately following the ballooning of the device the patient expired due to a ruptured thoracic aorta.The patient expired due to exsanguination.It was reported the patient¿s anatomy (extremely calcified landing zone and short aortic neck) are suspected to have contributed to the ruptured thoracic aorta.
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