GRAFTMASTER

Additional Manufacturer Narrative

A VISUAL INSPECTION AND DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED STENT DISLODGMENT WAS CONFIRMED. THE REPORTED FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. 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 REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED DEVICE ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. 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

IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOSITY LESION IN THE LEFT ANTERIOR DESCENDING (LAD). REPORTEDLY A 2.80X16MM, 2.80X19MM AND A 2.80X26 MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WERE ATTEMPTED TO BE USED TO TREAT A PERFORATION; HOWEVER, THEY WERE ALL UNABLE TO CROSS THE LESION DUE TO THE CALCIFICATION. BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT THE PERFORATION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY REPORTED INFORMATION, THE 2.80 X 16MM GRAFTMASTER WAS RECEIVED AND THE ANALYSIS REVEALED THAT THE STENT IMPLANT WAS STATIONARY ON THE BALLOON BUT NOT BETWEEN THE MARKERS. THE DISTAL END OF THE STENT IMPLANT WAS 1MM PROXIMAL TO THE DISTAL BALLOON SHOULDER. THE PROXIMAL END OF THE STENT IMPLANT WAS LOCATED 3MM DISTAL TO THE PROXIMAL BALLOON MARKER. THE ACCOUNT CONFIRMED THAT THE MISLOCATED STENT OCCURRED DURING THE PROCEDURE. 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 DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOSITY LESION IN THE LEFT ANTERIOR DESCENDING (LAD). REPORTEDLY A 2.80X16MM, 2.80X19MM AND A 2.80X26 MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WERE ATTEMPTED TO BE USED TREAT A PERFORATION; HOWEVER, THEY WERE ALL UNABLE TO CROSS THE LESION DUE TO THE CALCIFICATION . BALLOON ANGIOPLASTY WAS PERFORMED TO TREATED THE PERFORATION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.