MULTI-LINK 8

Additional Manufacturer Narrative

A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED MATERIAL SEPARATION WAS CONFIRMED. THE REPORTED FAILURE TO ADVANCE COULD NOT BE EVALUATED AS THE EXACT ANATOMICAL CONDITIONS ENCOUNTERED BY THE DEVICE USED DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST LABORATORY. 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 ANALYSIS, THE REPORTED MATERIAL SEPARATION APPEARS TO BE RELATED TO THE USE ERROR. THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. 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. IN THIS CASE, IT IS LIKELY THE DEVICE INTERACTED WITH THE MODERATELY CALCIFIED, HEAVILY TORTUOUS, 85% STENOSED LESION DURING ADVANCEMENT, AS RESISTANCE WAS NOTED, CAUSING THE REPORTED FAILURE TO ADVANCE. FURTHER MANIPULATION OF THE DEVICE INCLUDING USE OF FORCE DURING ADVANCEMENT LIKELY CONTRIBUTED TO THE REPORTED MATERIAL SEPARATION. THE MULTI-LINK 8 INSTRUCTIONS FOR USE (IFU) STATES SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING LESION ACCESS OR DELIVERY SYSTEM REMOVAL, THE ENTIRE GUIDING CATHETER AND STENT SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND DELIVERY SYSTEM COMPONENTS. 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.

Additional Manufacturer Narrative

H6 MEDICAL DEVICE PROBLEM CODE: 2017 - EXCESSIVE FORCE. 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 THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY. THE LESION WAS PRE-DILATED WITH A NON-ABBOTT BALLOON. THE 2.50 X 33 MM RX MULTILINK 8 STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER RESISTANCE WAS MET WITH THE LESION THEREFORE THE PHYSICIAN PUSHED HARD AND THE HYPOTUBE SEPARATED OUTSIDE THE PATIENT ANATOMY. THE SEPARATED PORTION WAS SIMPLY WITHDRAWN. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.