THE INCIDENT INFORMATION WAS REVIEWED; HOWEVER, THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. RETURN OF THE GUIDE WIRE MAY HAVE FURTHER AIDED THE ANALYSIS. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD (ELHR), CORRECTIVE ACTION TRACKING SYSTEM FOR THE WEB (CATSWEB) DATABASE REVIEW AND SIMILAR INCIDENT QUERY FOR THIS PRODUCT WAS NOT PERFORMED SINCE THE LOT NUMBER WAS NOT REPORTED. THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRE DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTY TO ADVANCE/POSITION THE GUIDE WIRE RESULTING IN A TIP SEPARATION APPEARS TO BE RELATED TO OPERATIONAL CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE 3.0X38MM XIENCE IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT #.
D
Patient 1
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. DURING ADVANCEMENT OF A WHISPER GUIDE WIRE THE TIP BECAME TRAPPED WITH AN IMPLANTED 3.0X38MM XIENCE STENT THAT WAS IMPLANTED IN THE SAME PROCEDURE. THE PHYSICIAN PULLED BACK THE GUIDE WIRE AND BECAME SEPARATED. THE TIP WAS EMBEDDED INTO THE VESSEL WALL WITH TWO MORE XIENCE STENTS. THERE WERE NO ADVERSE PATIENTS SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.