Information was provided to the manufacturer on (b)(6) 2011: the filter was placed on (b)(6) 2010.
Physician felt the landing was picture perfect, straight up and down in the vena cava with no tilt.
The patient started having pains and imaging revealed that the filter legs were protruding through the inferior vena cava.
On (b)(6) 2011, the physician tried to remove the filter in cath lab with a cook retrieval kit; however, he was unable to do so because the hook had tilted into the left renal vein.
He decided to bring the patient back to the operating room under sedation.
So, on (b)(6) 2011, he attempted to remove filter again with a cook retrieval kit.
The case did not go well, issues snaring and retrieving it.
Eventually part of the snare broke off and floated up into the right pulmonary middle lobe.
At this point the procedure was aborted and the foreign body was retrieved with a snare.
This caused rapid ventricular rate but the patient still had stable blood pressure.
After second procedure there was no evidence of extravasation.
The physician has consulted a colleague and another physician will be performing in open procedure to remove the filter.
Update received (b)(6) 2011: the patient had her filter removed via open procedure and she is doing well.
Patient is scheduled to go home (b)(6) 2011.