Vascutek ltd.Was notified of an event that occurred in (b)(6), the event was described as follows: bifurcated graft implanted (b)(6) 2017 for aaa.Typical postop surveillance was normal.Blood loss in first case documented at 1500ml.Patient presented at hospital on (b)(6) 2018 with a frank intraperitoneal aaa rupture despite his prior repair.On exploration, there was a 3-4mm hole in the limb which had to be repaired.Clearly far too big to be a missed hole in the graft at time of implant (the bleeding was pretty catastrophic).Surgeon that completed repair noted "a tremendous amount of blood was evacuated from the peritoneal cavity with lots of clots and lots of blood, lots of fluid was removed." the anaesthetist documented that blood loss was challenging to discern due to the number of blood clots.Hole was not located within the first centimetre past the crotch, so not consistent with a clamp injury location.No calcifications on the surrounding aortic sac that could have eroded the graft.Graft was straight so not at a flexion point.
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