MULTI-LINK 8

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 TO TREAT 80% STENOSED DE NOVO LESIONS IN THE LEFT CIRCUMFLEX (LCX) ARTERY AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. IN THE LCX A NON-ABBOTT GUIDE WIRE WAS ADVANCED TO THE TARGET LESION FOLLOWED BY PRE-DILATATION. THE 3X38MM MULTI-LINK BALLOON EXPANDING STENT (BES) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, THE BES FAILED TO CROSS DUE TO THE ANATOMY AND THE HYPOTUBE OF THE BES WAS NOTED TO BECOME SEPARATED OUTSIDE THE PATIENT ANATOMY. THEREFORE, THE BES WAS REMOVED FROM THE PATIENT AND A NON-ABBOTT STENT WAS USED TO TREAT THE LCX. AFTER PRE-DILATION OF THE LAD, THE 2.5X48MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION IN THE LAD; HOWEVER, THE XIENCE SKYPOINT SDS FAILED TO CROSS DUE TO THE ANATOMY AND THE DISTAL EDGE STENT STRUTS WERE NOTED TO BECOME FLARED. THEREFORE, THE XIENCE SKYPOINT SDS WAS REMOVED FROM THE PATIENT. A NON-ABBOTT STENT WAS USED TO TREAT THE LAD. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

A VISUAL, FUNCTIONAL, 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 FAILURE TO ADVANCE AND MATERIAL SEPARATION APPEAR TO BE RELATED TO THE 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, MODERATELY TORTUOUS, 80% 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. IT WAS REPORTED THAT THE 3.0 X 38MM RX MULTI-LINK 8 WAS ADVANCED; HOWEVER, RESISTANCE WAS MET WITH THE LESION AND FORCE WAS APPLIED, SEPARATING THE HYPOTUBE OUTSIDE THE PATIENT ANATOMY. 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. H6: MEDICAL DEVICE PROBLEM CODE 2017- EXCESSIVE FORCE.

Description of Event or Problem

SUBSEQUENT TO THE INITIAL REPORTED BEING FILED, IT WAS REPORTED THAT EXCESSIVE FORCE WAS APPLIED WHEN ATTEMPTING TO CROSS THE MULIT-LINK STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.