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 THAT THE PROCEDURE PERFORMED WAS TO TREAT A PERFORATION IN A HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 2.80X19MM GRAFTMASTER COVERED STENT FAILED TO CROSS DUE TO ANATOMY. A NEW 3.5X19MM GRAFTMASTER COVERED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED STENT DISLODGEMENT WAS CONFIRMED. 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, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. 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. STENT DISLODGEMENT MAY BE ATTRIBUTED TO SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, POSITIVE PRESSURE DURING PREPARATION, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREPARATION, AND INTERACTION WITH PATENT ANATOMY OR ACCESSORY DEVICES. IN THIS CASE, IT IS POSSIBLE THE DEVICE MAY HAVE INTERACTED WITH THE HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION DURING ADVANCEMENT, RESULTING IN THE REPORTED FAILURE TO ADVANCE. FURTHER INTERACTION WITH THE CHALLENGING ANATOMY DURING RETRACTION OF THE DEVICE MAY HAVE CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT IN ADDITION TO THE OBSERVED MANGLED AND BENT STENT AND NYLON SLEEVE; HOWEVER, 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.

Description of Event or Problem

SUBSEQUENTLY, IT WAS NOTED THAT STENT DISLODGED/DISLOCATED FROM THE BALLOON DURING THE PROCEDURE AND WAS SIMPLY WITHDRAWN. NO ADDITIONAL INFORMATION WAS PROVIDED.