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 WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD). A 3.5X19MM GRAFTMASTER BALLOON EXPANDABLE STENT (BES) WAS ATTEMPTED TO BE ADVANCE INTO THE LESION TO TREAT A PERFORATION; HOWEVER, FAILED TO CROSS DURING THE LESION COMPLEXITY. THEREFORE A XIENCE SIERRA DRUG-ELUTING STENT (DES) WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAILURE TO ADVANCE WAS NOT TESTED AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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 OF SPECIFIC ISSUE. BASED ON OBSERVATIONS FROM THE RETURNED ANALYSIS, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IT IS LIKELY THE DEVICE INTERACTED WITH THE CHALLENGING ANATOMY WHICH WAS DESCRIBED AS HEAVILY CALCIFIED AND HEAVILY TORTUOUS RESULTING IN FAILURE TO ADVANCE. THE ADDITIONAL DAMAGE AND SEPARATIONS WERE NOT REPORTED AND LIKELY OCCURRED DURING POST-PROCEDURE HANDLING. 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

DEVICE RETURN STATUS REVEALED THAT THE JACKETED HYPOTUBE WAS SEPARATED ROM THE STRAIN RELIEF TUBING. THE ACCOUNT DECLINED TO PROVIDE ADDITIONAL INFORMATION NO ADDITIONAL INFORMATION WAS PROVIDED.