GRAFTMASTER

Description of Event or Problem

IT WAS REPORTED THAT AFTER THE HEAVILY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY WAS STENTED AT THE CALCIFIED SEGMENT, A SMALL PERFORATION DISTAL TO THE STENT WAS NOTED. TWO 2.8X19 MM GRAFTMASTER STENTS WERE INSERTED TO TREAT THE PERFORATION, BUT THEY WERE UNABLE TO CROSS. BALLOON ANGIOPLASTY WAS PERFORMED TO SEAL THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

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 SPECIFIC ISSUE. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT, 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. D9: CORRECTED DEVICE AVAILABLE FOR EVALUATION FROM YES TO NO.

Description of Event or Problem

N/A