THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS AND/OR COMPLAINTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECTS TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.
D
Patient 1
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. RESISTANCE WAS MET DURING ADVANCEMENT, DUE TO THE PATIENT ANATOMY. THE 5.0 X 8 MM NC TRAVELER DILATATION CATHETER WAS INFLATED TO PERFORM POST DILATATION OF A XIENCE SIERRA STENT. DURING INFLATION TO 10 ATMOSPHERES (ATM), THE BALLOON RUPTURED. IT WAS NOTED THAT THE AIR PRESSURE INSIDE THE INDEFLATOR FAILED TO RISE AND CONTRAST LEAKAGE WAS NOTED ON ANGIOGRAPHY. THE NC TRAVELER DILATATION CATHETER WAS REMOVED WITHOUT RESISTANCE AND POST DILATATION WAS PERFORMED USING A NON-ABBOTT DILATATION CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.