THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION DETERMINED THE REPORTED FAILURE TO ADVANCE AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IN THIS CASE, IT IS LIKELY THE DEVICE INTERACTED WITH THE HEAVILY TORTUOUS, HEAVILY CALCIFIED LESION DURING ADVANCEMENT RESULTING IN THE REPORTED FAILURE TO ADVANCE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.
D
Patient 1
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NON-ST-ELEVATED MYOCARDIAL INFARCTION. THE HEAVILY TORTUOUS AND HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY WAS BEING TREATED; HOWEVER, THE VESSEL RUPTURED DURING DILATATION WITH AN UNSPECIFIED BALLOON CATHETER. AN ATTEMPT TO USE A 2.8X19MM RX GRAFTMASTER COVERED STENT WAS MADE, BUT IT FAILED TO CROSS DUE TO THE ANATOMY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BALLOON ANGIOPLASTY. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.