GRAFTMASTER

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. A CONCLUSIVE CAUSE FOR THE REPORTED ACTIVATION FAILURE COULD NOT BE DETERMINED; HOWEVER, FACTORS THAT MAY CONTRIBUTE TO AN ACTIVATION FAILURE INCLUDING EXPANSION FAILURES INCLUDE, BUT ARE NOT LIMITED TO, INFLATION TECHNIQUE, CONTRAST CONCENTRATION, LOOSE CONNECTION WITH THE INDEFLATOR, ANATOMICAL CONDITIONS, CONTAMINATION IN THE INFLATION LUMEN OR DAMAGE TO THE GUIDE WIRE AND/OR INFLATION LUMEN. IN THIS CASE, IT IS POSSIBLE THAT THE DEVICE MAY HAVE INTERACTED WITH ACCESSORY DEVICES OR THE HEAVILY CALCIFIED/STENOSED LESION DURING ADVANCEMENT, CAUSING THE DEVICE TO BECOME DAMAGED DURING ADVANCEMENT/POSITIONING, ULTIMATELY CAUSING THE REPORTED ACTIVATION FAILURE; HOWEVER, BASED ON THE INFORMATION PROVIDED AND WITHOUT THE DEVICE TO EXAMINE, THIS CANNOT BE CONFIRMED. THERE WAS NO DAMAGE NOTED TO THE STENT DELIVERY SYSTEM (SDS) DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT QUALITY ISSUE DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. 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 HEAVILY STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD). A 2.80X16MM GRAFTMASTER BALLOON EXPANDABLE STENT (BES) WAS ATTEMPTED TO BE USED TO TREAT A PERFORATION; HOWEVER, FAILED TO DEPLOY. THEREFORE, THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT DEVICE. THERE WERE NO ADVERSE PATIENT SEQUELA NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.