Concomitant medical devices: as gore was unable to determine which device was involved in the event if any; additional device(s) associated include: mob37/20317994, udi: (b)(4), mob37/20317983, udi: (b)(4).Patient medications include but are not limited to: norvasc, cozaar, ativan, lipitor, prilosec, k-dur, klor-con, vitamin d, tylenol.Pma/510(k) #: k172567.(b)(4).
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On (b)(6) 2020, this patient underwent endovascular treatment for an enlarging 5.5cm abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.It was reported that post deployment of the devices a proximal type i endoleak was seen and a gore® aortic extender component was placed proximally.During angioplasty of the aortic extender component using a gore® molding & occlusion balloon (mob), increased extravasation was seen and angiography determined a rupture at the origin of the left renal artery due to suspected over inflation of the balloon.Reportedly due to the patient's short angulated neck coupled with calcification in the aortic neck; good seal was unable to be achieved.The physician converted to open repair wherein grafts were sewn in to reline the devices.Massive transfusion protocol was initiated for the patient who was transfused with 11 litres.The procedure was concluded with an "open" close for the patient, with a plan was to reintervene the next day and perform an ax femoral bypass.On (b)(6) 2020, the patient expired.The cause of death was not available.
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