THE IMPELLA RP WAS RETURNED FOR INVESTIGATION. THE STRUTS OF THE OUTFLOW CAGE WERE FOUND TO HAVE FAILED AT THE SOLDER JOINT BETWEEN THE STRUT AND BALL OF THE OUTFLOW CAGE. ACCORDING TO THE PHYSICIAN, THE PATIENT'S ILIAC VEIN WAS "VERY TORTUOUS." THE DAMAGE TO THE STRUTS ON THE OUTFLOW CAGE MAY HAVE OCCURRED WHILE THE PUMP WAS PASSING THROUGH THE INTRODUCER, WHICH HAD KINKED DUE TO THE ILIAC TORTUOSITY. THE ROOT CAUSE OF THE PUMP DAMAGE IS LIKELY DELIVERY THROUGH THE KINKED INTRODUCER AS A RESULT OF THE ILIAC TORTUOSITY, HOWEVER THIS CANNOT BE CONFIRMED. THEREFORE, THE VASCULAR PERFORATION WAS LIKELY CAUSED BY THE DAMAGED STRUTS OF THE OUTFLOW CAGE, HOWEVER THIS CANNOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY DID NOT REVEAL ANY ABNORMALITIES. (B)(4).
D
Patient 1
AN (B)(6) YEAR OLD MALE PATIENT PRESENTED TO THE CARDIAC CATH LAB POST-CABG AND WITH DECREASING CARDIAC INDEX. THE DECISION WAS MADE TO IMPLANT AN IMPELLA RP FOR SUPPORT. THE PATIENT'S ILIAC VEIN WAS NOTED TO BE VERY TORTUOUS ACCORDING TO THE IMPLANTING PHYSICIAN. AS THE PHYSICIAN ATTEMPTED TO MANIPULATE THE PUMP INTO PLACE, THE PEEL AWAY INTRODUCER WAS DAMAGED, AND THE CATHETER PORTION OF PUMP EXITED THE SIDE OF THE DAMAGED INTRODUCER AND PERFORATED THE PATIENT'S ILIAC VEIN. THE PATIENT'S VEIN WAS SURGICALLY REPAIRED WITH COVERED STENTS AND BLOOD REPLACEMENT PRODUCTS WERE GIVEN. THE DECISION WAS MADE TO ABORT THE PLACEMENT OF THE IMPELLA RP AS THE PATIENT'S CONDITION HAD IMPROVED TO THE POINT WHERE THERE WAS NO IMMEDIATE NEED FOR OTHER SUPPORT.