Description of Event or Problem · 1
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A (B)(6) YEAR OLD MALE PATIENT UNDERWENT A TVAR PROCEDURE IN WHICH THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS, G35367, WAS USED. THE LAST GRAFT PIECE, G35367, WAS USED FOR BRIDGING BETWEEN TWO GRAFTS AS THE PROXIMAL GRAFT WAS TOO SHORT WITH THE DISTAL PIECE. WHEN THE PHYSICIAN FINISHED AND ROTATED THE DELIVERY SYSTEM THE NOSE CONE OF THE DEVICE INNER WHITE CANNULA CAME OFF AND STAYED ON THE WIRE END OF THE GRAFT. LEAVING THE NOSE CONE AND INNER CANNULA IN THE PATIENT. THE PHYSICIAN THEN ADVANCED A LONGER AND LARGER SHEATH AND SNARED THE SHEATH TO REMOVE FROM THE PATIENT. ADDITIONAL INFORMATION RECEIVED 20MAR2020: AFTER RELEASING THE STENT GRAFT, THE PHYSICIAN RETRIEVED THE INNER SYSTEM AND LEFT THE OUTER SHEATH IN ORDER TO PERFORM BALLOONING. WHEN THE INNER SYSTEM WAS TAKEN OUT, IT WAS NOTED THAT THE SYSTEM ONLY CONTAINED THE GREY POSITIONER ALONG WITH THE HANDLE AND THE TIP ASSEMBLY (DILATOR TIP AND CANNULA) WAS LEFT IN PATIENT. THERE WAS VERY TORTUROUS ANATOMY AND WE WERE WELL IN THE ARCH AROUND ZONE 2. SOME DIFFICULTY RETRIEVING DEVICE OVER THE ARCH BUT AS EXPECTED WITH THE ANATOMY AND SIZE OF ANEURYSM. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.