GRAFTMASTER

Additional Manufacturer Narrative

PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAILURE TO ADVANCE COULD NOT BE EVALUATED AS THE EXACT ANATOMICAL CONDITIONS ENCOUNTERED BY THE DEVICE USED DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST LABORATORY. BASED ON THE INFORMATION RECEIVED AND ANALYSIS OF THE RETURNED DEVICE, THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT, AS IT IS LIKELY THE DEVICE INTERACTED WITH THE HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION DURING ADVANCEMENT, RESULTING IN THE REPORTED FAILURE TO ADVANCE AND OBSERVED MATERIAL DEFORMATION (FLARED DISTAL STENT STRUTS). ADDITIONAL FOLLOW UP WITH THE ACCOUNT CONFIRMED THE OBSERVED MATERIAL SEPARATION DID NOT OCCUR DURING THE PROCEDURE AND LIKELY HAPPENED DURING HANDLING/PACKAGING FOR RETURN TO ABBOTT VASCULAR FOR ANALYSIS. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE 2.8 X 26 MM GRAFTMASTER COVERED STENT DID NOT CROSS THE HEAVILY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE LEFT CIRCUMFLEX CORONARY ARTERY TO TREAT A DISSECTION. ANOTHER GRAFTMASTER COVERED STENT WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.