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 DE NOVO, MILDLY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. THE 2.80X26MM GRAFTMASTER COVERED STENT FAILED TO CROSS THE LESION DUE TO ANATOMY. A NEW GRAFTMASTER COVERED STENT WAS USED TO TREAT THE PERFORATION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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 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 MILDLY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION DURING ADVANCEMENT, CAUSING THE REPORTED FAILURE TO ADVANCE; HOWEVER, BASED ON THE INFORMATION PROVIDED BY THE ACCOUNT AND 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. D9 CORRECTION: DEVICE AVAILABLE FOR EVALUATION UPDATED FROM YES TO NO.

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 MILDLY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION DURING ADVANCEMENT, CAUSING THE REPORTED FAILURE TO ADVANCE. FURTHER INTERACTION WITH THE CHALLENGING ANATOMY DURING RETRACTION OF THE DEVICE MAY HAVE CONTRIBUTED TO THE OBSERVED MATERIAL DEFORMATION AND DISLODGED STENT; HOWEVER, BASED ON THE INFORMATION PROVIDED BY THE ACCOUNT, 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, AFTER THE INITIAL REPORT HAD ALREADY BEEN FILED, RETURNED DEVICE ANALYSIS OBSERVED THE PROXIMAL END OF THE STENT PASSED THE PROXIMAL MARKER. NO ADDITIONAL INFORMATION WAS PROVIDED.