GRAFTMASTER

Additional Manufacturer Narrative

A VISUAL INSPECTION AND DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. BASED ON THE INFORMATION RECEIVED AND ANALYSIS OF THE RETURNED DEVICE, 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, MILDLY TORTUOUS ANATOMY DURING ADVANCEMENT, RESULTING IN THE REPORTED FAILURE TO ADVANCE, CAUSING THE OBSERVED KINKED HYPOTUBE. 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. CORRECTION B2 - OUTCOMES ATTRIBUTED TO AE UPDATED TO OTHER SERIOUS

Additional Manufacturer Narrative

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. CORRECTION TO H11 - ADDITIONAL MFG NARRATIVE: UPDATED.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. DURING PRE-DILATATION A PERFORATION OCCURRED; THEREFORE, THE 2.8X19MM GRAFTMASTER COVERED STENT SYSTEM WAS ATTEMPTED TO BE ADVANCED TO TREAT THE PERFORATION; HOWEVER, THE GRAFTMASTER FAILED TO CROSS DUE TO THE ANATOMY. A GUIDELINER WAS INSERTED AND ANOTHER 2.8X19MM AND A 2.8X16MM GRAFTERMASTER STENTS WERE ATTEMPTED TO CROSS THE TARGET AND THE STENTS ALSO FAILED TO CROSS DUE TO THE ANATOMY. THEREFORE, A CORONARY ARTERY BYPASS GRAFT PROCEDURE WAS PERFORMED TO TREAT THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 TWO ADDITIONAL DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.