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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE. THE REPORTED PATIENT EFFECT OF INTIMAL DISSECTION IS LISTED IN THE XIENCE XPEDITION, EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS), INSTRUCTIONS FOR USE, AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE.
D
Patient 1
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED DE NOVO LEFT ANTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED. A 2.75X38MM XIENCE XPEDITION STENT WAS IMPLANTED WITHOUT ISSUE. AFTER IMPLANTING THE STENT, A DISSECTION AT THE DISTAL EDGE WAS NOTED. ANOTHER STENT WAS USED TO COVER THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.