GRAFTMASTER

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 THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. A STENT WAS IMPLANTED HOWEVER A SMALL PERFORATION WAS NOTED DISTAL TO THE STENT. THE 3.50X19MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO COVER THE PERFORATION HOWEVER FAILED TO CROSS THE LESION. THE SDS WAS REMOVED AND AN ATTEMPT WAS MADE WITH ANOTHER SAME SIZE GRAFTMASTER; HOWEVER IT TOO FAILED TO CROSS THE LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Description of Event or Problem

SUBSEQUENT TO THE INITIALLY FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE DISTAL TIP OF THE DEVICE WAS SEPARATED AND NOT RETURNED. FOLLOW UP INFORMATION CONFIRMED THE SEPARATION OCCURRED DUE TO HANDLING POST PROCEDURE DURING PACKING FOR RETURN ANALYSIS.

Additional Manufacturer Narrative

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. 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. 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 THE OPERATIONAL CONTEXT OF THE PROCEDURE, AS IT IS LIKELY THE DEVICE INTERACTED WITH THE HEAVILY CALCIFIED, MODERATELY TORTUOUS LESION DURING ADVANCEMENT, RESULTING IN THE REPORTED FAILURE TO ADVANCE. 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.