GRAFTMASTER

Description of Event or Problem

IT WAS REPORTED IN A CASE STUDY THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) OF THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY ACCOMPANIED BY A SUBSTANTIAL, THIN-WALLED ANEURYSM AND A SMALLER ANEURYSM. THE GRAFTMASTER COVERED STENT WAS ADVANCE TO THE PROXIMAL LEFT CIRCUMFLEX (LCX) INTO DISTAL LEFT MAIN (LM) ARTERY AND THE STENT WAS IMPLANTED. POST-DILATATION WAS PERFORMED ON THE STENT; HOWEVER, RESIDUAL FLOW AROUND THE STENT WAS NOTED. THEREFORE, MULTIPLE COIL DEVICES USED TO ACHIEVE EMBOLIZATION OF THE PROXIMAL TO MID PSEUDOANEURYSM. THERE WAS NO ADVERSE PATIENT SEQUELA. ADDITIONAL INFORMATION CAN BE FOUND IN THE ONLINE JOURNAL ARTICLE, "MANAGEMENT DILEMMA: MULTIDISCIPLINARY APPROACH FOR MANAGEMENT OF LEFT ANTERIOR DESCENDING ARTERY PSEUDOANEURYSM."

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PART NUMBER AND/OR LOT NUMBER WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENT APPEARS TO BE RELATED TO OPERATIONAL CONTEXT 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. IT SHOULD BE NOTED THAT THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM INSTRUCTION FOR USE STATES: THE GRAFTMASTER RX IS INDICATED FOR USE IN THE TREATMENT OF FREE PERFORATIONS, DEFINED AS FREE CONTRAST EXTRAVASATION INTO THE PERICARDIUM, IN NATIVE CORONARY VESSELS OR SAPHENOUS VEIN BYPASS GRAFTS. IN THIS CASE, THE INSTRUCTION FOR USE (IFU) DEVIATION RELATED TO INDICATIONS FOR USE DEVIATION DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED EVENT. B3, B6, AND D6A: ESTIMATED DATES. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. H6: 1494 OFF LABEL USE (INDICATION FOR USE). ATTACHMENT ARTICLE TITLED, "MANAGEMENT DILEMMA: MULTIDISCIPLINARY APPROACH FOR MANAGEMENT OF LEFT ANTERIOR DESCENDING ARTERY PSEUDOANEURYSM".