GRAFTMASTER

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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, A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. FACTORS WHICH MAY CONTRIBUTE TO DIFFICULTY ADVANCING THE DEVICE IN THE GUIDING CATHETER INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, DAMAGE TO THE STENT, DAMAGE TO THE GUIDING CATHETER, GUIDING CATHETER SIZE SELECTION OR PROCEDURAL TECHNIQUE (DEVICES NOT PROPERLY SUPPORTED OR COAXIALLY ALIGNED). FACTORS THAT COULD CONTRIBUTE TO FAILURE TO ADVANCE INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, INTERACTION WITH PREVIOUSLY PLACED STENTS OR ACCESSORY DEVICES. FACTORS THAT CAN CONTRIBUTE TO DIFFICULT TO REMOVE INCLUDE, BUT ARE NOT LIMITED TO, KINKS, BENDS, PROCEDURAL TECHNIQUE, INSUFFICIENT SUPPORT, OR INTERACTIONS WITH OTHER DEVICES. IN THIS CASE, IT IS POSSIBLE THE DEVICE MAY HAVE INTERACTED WITH THE MILDLY CALCIFIED, MODERATELY TORTUOUS LESION DURING ADVANCEMENT, AS RESISTANCE WAS NOTED, RESULTING IN THE REPORTED FAILURE TO ADVANCE. FURTHER INTERACTION WITH ACCESSORY DEVICES (GUIDE CATHETER) DURING ADVANCEMENT/RETRACTION (DEVICES NOT PROPERLY SUPPORTED OR COAXIALLY ALIGNED) MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULT TO ADVANCE AND DIFFICULT TO REMOVE; HOWEVER, WITHOUT THE DEVICE TO EXAMINE, THIS CANNOT BE CONFIRMED. 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 PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY. THE 3.5X19MM GRAFTMASTER COVERED STENT FAILED TO CROSS AS RESISTANCE WAS NOTED WITH GUIDING CATHETER AND ANATOMY. BOTH DEVICES WERE REMOVED TOGETHER AS ONE UNIT. ANOTHER GRAFTMASTER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.