JOSTENT GRAFTMASTER

Description of Event or Problem

THE ARTICLE DOCUMENTS A CASE OF A 19-YEAR OLD PATIENT WITH A SMALL PSEUDOANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY (ICA) IN THE CAVERNOUS SEGMENT. REPEAT CT ANGIOGRAPHY 2 MONTHS AFTER THE INJURY DEMONSTRATED SIGNIFICANT INCREASE IN SIZE OF THE PSEUDOANEURYSM WITH DEVELOPMENT OF MORE PROMINENT ENHANCEMENT OF THE VEINS IN THE REGION, SUGGESTIVE OF AN AV FISTULA. AN EXCELSIOR SL-10 MICROCATHETER WAS ADVANCED OVER A SYNCHRO 2 MICROWIRE ACROSS THE CAVERNOUS ICA AND INTO THE PROXIMAL LEFT M2 SEGMENT. THE MICROWIRE WAS REMOVED AND THE SL-10 WAS EXCHANGED OVER AN EXCHANGE LENGTH TRANSEND 014 WIRE. A 4.8×19 MM GRAFTMASTER CORONARY STENT GRAFT WAS LOADED ONTO THE MICROWIRE AND WAS ADVANCED INTO THE CAVERNOUS ICA. THE BALLOON WAS INFLATED TO A MAXIMAL PRESSURE OF 15 ATMOSPHERES AND THE STENT WAS DEPLOYED WITHOUT DIFFICULTY. ANGIOGRAPHY DEMONSTRATED A TINY PERSISTENT FISTULA. TO PREVENT ENDOLEAK, THE STENT BALLOON WAS REMOVED AND A 6×12MM ANGIOPLASTY BALLOON WAS ADVANCED OVER THE RX SYSTEM INTO THE MID STENT. THE BALLOON WAS INFLATED TO A MAXIMAL PRESSURE OF 6 ATMOSPHERES, RESULTING IN IMPROVED WALL APPOSITION OF THE STENT. THE BALLOON WAS REMOVED, AND ANGIOGRAPHY CONFIRMED NO RESIDUAL FISTULA. NEXT, THE OPHTHALMIC PSEUDOANEURYSM WAS COILED, USING PENUMBRA SMART COILS, AND THE FINAL ANGIOGRAPHY DEMONSTRATED NO EVIDENCE OF THROMBOEMBOLIC OR HEMORRHAGIC COMPLICATION. THE ARTICLE STATED THAT THE BALLOON-EXPANDING COVERED STENTS, SUCH AS JOSTENT CORONARY STENT GRAFTS HAVE SUFFICIENT RADIAL STRENGTH TO PROVIDE THE DESIRED INTRALUMINAL SUPPORT IN PARENT ARTERY; HOWEVER, THEIR POOR LONGITUDINAL FLEXIBILITY LEADS TO DIFFICULT STENT DELIVERY IN TORTUOUS VESSELS AND INCREASES THE RISK OF VESSEL SPASM, DISSECTION AND PERFORATION DUE TO THE FRICTION BETWEEN THE STENT AND VESSEL WALL. THE ARTICLE CONCLUDED THAT DESPITE THE LACK OF OPTIMAL FLEXIBILITY, THE BALLOON-EXPANDABLE COVERED STENTS CAN BE CONSIDERED AS AN EFFECTIVE ALTERNATIVE TREATMENT FOR HIGH-FLOW DIRECT CAROTID CAVERNOUS FISTULAS (DCCF) WITH A TORTUOUS INTRACRANIAL ICA NOT AMENABLE TO COIL EMBOLIZATION. DETAILS ARE LISTED IN THE ARTICLE TITLED, ¿COVERED STENT DELIVERY IN TORTUOUS INTERNAL CAROTID ARTERY FOR TREATMENT OF DIRECT CAROTID CAVERNOUS FISTULA". NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. ATTACHMENT ARTICLE TITLED, ¿COVERED STENT DELIVERY IN TORTUOUS INTERNAL CAROTID ARTERY FOR TREATMENT OF DIRECT CAROTID CAVERNOUS FISTULA". B3- FOR REPORTING PURPOSES, THE DATE OF PROCEDURE WILL BE ESTIMATED AS 5/01/2021 AS THE ARTICLE WAS RECEIVED 11/08/2021 AND FOLLOW UP WAS PERFORMED ON THE PATIENT 6 MONTHS POST PROCEDURE. D4- THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. H6- MEDICAL DEVICE PROBLEM CODE 1494 CLARIFIER: INDICATION FOR USE/ INCORRECT ANATOMY.

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 FAILURE TO SEAL COULD NOT BE DETERMINED; HOWEVER, FAILURE TO SEAL THE PERFORATION MAY BE ATTRIBUTED TO SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PRODUCT SIZE SELECTION, DEPLOYMENT TECHNIQUE (NON-CENTRAL POSITIONING OF STENT GRAFT OVER PERFORATION OR INADEQUATE OVERLAPPING), INTERFERENCE FROM PREVIOUSLY DEPLOYED DEVICES, OR GROWTH OF PERFORATION DURING DEPLOYMENT. THE REPORTED DIFFICULTY TO ADVANCE AND MATERIAL TOO SOFT/FLEXIBLE APPEARS TO BE RELATED TO OPERATION CONTEXT OF THE PROCEDURE AS IT IS LIKE THE DEVICE INTERACTED WITH THE TORTUOUS VESSEL RESULTING IN THE REPORTED DIFFICULTIES ADVANCING. ADDITIONALLY, THE DEVICE WAS PLACED IN INTERNAL CAROTID ARTERY TO TREAT A FISTULA AGAINST THE GRAFTMASTER INSTRUCTIONS FOR USE WHICH MAY HAVE CONTRIBUTED TO THE POOR PERFORMANCE OF THE PRODUCT. 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.