Critically ill patient underwent a nephrectomy and had to return to surgery for bleeding where it was discovered the hemorrhage was from the right adrenal gland with a clip failure.Additional clips remained partially occluding the renal vein, but not enough to stop blood flow.There was a small defect approximately 1 mm in the vena cava directly posterior to the vein, where the surgeon suspects the tip of the clip had pinched the vena cava when it was placed or when it failed, it made a small hole.Patient underwent a massive transfusion but ultimately was unable to recover from his surgery.Fda safety report id# (b)(4).
|