GRAFTMASTER

Description of Event or Problem

IT WAS REPORTED IN A GENERAL COMMENT WITHIN A SINGLE CASE STUDY REGARDING COVERED STENTS THAT THE GRAFTMASTER COVERED STENT CAN BE USED OFF LABEL TO TREAT CAROTID-CAVERNOUS FISTULA. THE GRAFTMASTER DELIVERY SYSTEM IS STIFF WITH POOR TRACKABILITY AND IN CASES OF SIGNIFICANT CAROTID TORTUOSITY IT MAY NOT BE POSSIBLE TO ADVANCE THE STENT TO THE TARGET LESION. LIKELY BECAUSE OF THESE SHORTCOMINGS, COMPLICATIONS SUCH AS ENDOLUMINAL LEAK, PERIPROCEDURAL VASOSPASM, DISSECTION, RUPTURE, AND THROMBOEMBOLISM HAVE BEEN REPORTED. ADDITIONAL INFORMATION CAN BE FOUND IN THE ARTICLE "PK PAPYRUS COVERED STENT TO TREAT TRAUMATIC PSEUDOANEURYSM OF THE INTERNAL CAROTID ARTERY, A TECHNICAL NOTE AND REVIEW OF THE LITERATURE".

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. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULT TO ADVANCE, FAILURE TO ADVANCE AND MATERIAL TOO RIGID (STIFF) WITH THE PATIENT EFFECTS OF HEMORRHAGE, VASOCONSTRICTION, DISSECTION, PERFORATION, THROMBOSIS, EMBOLISM AND SERIOUS INJURY/ILLNESS/IMPAIRMENT. THE INFORMATION RECEIVED IN THE COMPLAINT WAS OBTAINED THROUGH A PROACTIVE LITERATURE SEARCH. SPECIFIC MODEL AND LOT NUMBERS WERE NOT AVAILABLE AND CAUSALITY BETWEEN THE DOCUMENTED DEVICE USAGE AND THE PATIENT EFFECTS COULD NOT BE ESTABLISHED. IT WAS REPORTED IN A GENERAL COMMENT WITHIN A SINGLE CASE STUDY REGARDING COVERED STENTS THAT THE GRAFTMASTER COVERED STENT CAN BE USED OFF LABEL TO TREAT CAROTID-CAVERNOUS FISTULA. THE GRAFTMASTER DELIVERY SYSTEM IS STIFF WITH POOR TRACKABILITY AND IN CASES OF SIGNIFICANT CAROTID TORTUOSITY IT MAY NOT BE POSSIBLE TO ADVANCE THE STENT TO THE TARGET LESION. LIKELY BECAUSE OF THESE SHORTCOMINGS, COMPLICATIONS SUCH AS ENDOLUMINAL LEAK, PERIPROCEDURAL VASOSPASM, DISSECTION, RUPTURE, AND THROMBOEMBOLISM HAVE BEEN REPORTED. IT SHOULD BE NOTED THAT THE GRAFTMASTER RAPID EXCHANGE (RX), CORONARY STENT GRAFT SYSTEM, DOMESTIC INSTRUCTIONS 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 GREATER THAN OR EQUAL TO 2.75 MM IN DIAMETER. IT IS LIKELY THE IFU DEVIATION CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED PATIENT EFFECTS OF HEMORRHAGE, DISSECTION, PERFORATION, THROMBOSIS AND EMBOLISM ARE LISTED IN THE GRAFTMASTER CORONARY STENT GRAFT SYSTEM INSTRUCTIONS FOR USE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE GRAFTMASTER RX CORONARY STENT GRAFT IN NATIVE CORONARY ARTERIES. 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. B3: DATE OF EVENT ESTIMATED 09/22/2024. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. H6: MEDICAL DEVICE PROBLEM CODE: 1494 - INCORRECT ANATOMY, AND 1494 - INDICATION FOR USE. LITERATURE ATTACHMENT: ARTICLE TITLE "PK PAPYRUS COVERED STENT TO TREAT TRAUMATIC PSEUDOANEURYSM OF THE INTERNAL CAROTID ARTERY ¿ A TECHNICAL NOTE AND REVIEW OF THE LITERATURE."