GRAFTMASTER

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 PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED FAILURE TO ADVANCE 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. IN THIS CASE, IT IS POSSIBLE THE DEVICE MAY HAVE INTERACTED WITH THE MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION DURING ADVANCEMENT, CAUSING THE REPORTED FAILURE TO ADVANCE AND OBSERVED MATERIAL DEFORMATION (LIFTED AND BENT DISTAL STENT STRUTS) IN ADDITION TO THE OBSERVED BUNCHED INNER/OUTER MEMBER. FURTHER INTERACTION WITH THE CHALLENGING ANATOMY DURING RETRACTION OF THE DEVICE MAY HAVE CAUSED THE OBSERVED STRETCHED OUTER MEMBER; HOWEVER, BASED ON THE INFORMATION PROVIDED BY THE ACCOUNT, THIS CANNOT BE CONFIRMED. THE SDS WAS RETURNED SEPARATED FROM THE PROXIMAL END OF THE DEVICE. THE MATERIAL AT THE FRACTURE FACE WAS OVAL IN SHAPE. THE STENT IMPLANT WAS DISLODGED BUT STILL ON THE BALLOON. THE PROXIMAL END OF THE STENT WAS PASSED THE DISTAL MARKER. ADDITIONAL FOLLOW UP WITH THE ACCOUNT CONFIRMED THE CORRECT DEVICE WAS RETURNED. THE ACCOUNT ALSO CONFIRMED THE OBSERVED STENT DISLODGEMENT AND OBSERVED MATERIAL SEPARATION DID NOT OCCUR DURING THE PROCEDURE AND LIKELY OCCURRED DURING PACKAGING/SHIPMENT FOR RETURN TO ABBOTT VASCULAR. THERE WERE VISIBLE CRIMP MARKS WHERE THE STENT WAS INITIALLY CRIMPED ON, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE STRUTS ON THE FIRST TWO RINGS OF THE DISTAL END OF THE STENT WERE LIFTED AND BENT. THE OUTER MEMBER WAS STRETCHED AT THE PROXIMAL BALLOON SEAL LOCATION. THE INNER AND OUTER MEMBER WERE BUNCHED AT MULTIPLE LOCATIONS. THE GUIDEWIRE EXIT NOTCH WAS STRETCHED AND TORN. THIS TYPE OF MECHANICAL DAMAGE CAN OCCUR IF AN ATTEMPT IS MADE TO PULL THE CATHETER IN AN OPPOSITE DIRECTION AS THE GUIDE WIRE. IN ADDITION, IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISSECTION. IT SHOULD BE NOTED THAT THE GRAFTMASTER INSTRUCTIONS FOR USE, (IFU) STATES: THE GRAFTMASTER RX IS INDICATED FOR USE IN THE TREATMENT OF FREE PERFORATIONS, DEFINED AS FREE CONTRAST EXTRAVASATION INTO THE PERICARDIUM, IN NATIVE CORONARY VESSELS OR SAPHENOUS VEIN BYPASS GRAFTS GREATER THAN OR EQUAL TO 2.75 MM IN DIAMETER. IN THIS CASE, IT IS UNKNOWN IF THE IFU DEVIATION DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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. H6 MEDICAL DEVICE PROBLEM CODE: 1494 - INDICATION FOR USE.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. DURING THE PROCEDURE, A DISSECTION WAS NOTED; THEREFORE, THE 3.5X19MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED; HOWEVER, THE STENT FAILED TO CROSS DUE TO THE ANATOMY. ANOTHER 3.5X19MM GRAFTMASTER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND THE STENT IMPLANT WAS DISLODGED BUT STILL ON THE BALLOON. THE PROXIMAL END OF THE STENT WAS PASSED THE DISTAL MARKER 2MM. THE SDS SYSTEM WAS RETURNED SEPARATED 14CM FROM THE PROXIMAL END OF THE DEVICE. THE GUIDEWIRE EXIT NOTCH WAS STRETCHED AND TORN. NO ADDITIONAL INFORMATION WAS PROVIDED.