GELSEAL

Additional Manufacturer Narrative

(B)(4). METHOD: NO TESTING METHODS PERFORMED - NO INFORMATION ON THE GRAFT IDENTIFICATION WAS PROVIDED. THE MANUFACTURING AND QC RECORDS FOR THIS BATCH COULD NOT BE REVIEWED AS NO INFORMATION ON BATCH DETAILS WAS PROVIDED. VASCUTEK HAVE REQUESTED FURTHER INFORMATION ON THIS EVENT BUT WAS INFORMED THAT, BECAUSE GRAFT WAS IMPLANTED IN 1990 NO BATCH OR SERIAL NUMBER IS AVAILABLE. SIMILAR EVENTS REVIEW WAS CARRIED OUT FOR ALL KNITTED GRAFTS FOR LEAKAGE WHICH GAVE A LOW OCCURRENCE RATE OF 0.02% (COMPLAINTS V SALES). VASCUTEK IS AWAITING PIECE OF GRAFT TO BE RETURNED FOR FURTHER ANALYSIS.

Description of Event or Problem

THE EVENT, WHICH OCCURRED AT (B)(6) WAS REPORTED TO VASCUTEK AS BLOOD LEAKAGE FROM THE GRAFT. THE TIMELINE OF EVENTS IS AS FOLLOWS: ON (B)(6) 1990 VASCUTEK GRAFT WAS IMPLANTED IN THE PATIENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA). A LARGE AMOUNT OF BERIPLAST WAS USED ACCORDING TO THE RECORD. AN ANEURYSM WAS IDENTIFIED AND BLEEDING WAS SUSPECTED ON THE CRUTCH AREA OF THE GRAFT. ON (B)(6) 2014 A STENT GRAFT, AFX (JLL) WAS PLACED. NO CHANGE ON THE ANEURYSM. ON (B)(6) 2016 A STRAIGHT STENT GRAFT WAS PLACED ON THE RIGHT SIDE, AS THE ANASTOMOTIC SITE OF THE RIGHT GRAFT GOT TORN AND BLEEDING OCCURRED. ON (B)(6) 2018 AS LEAKAGE BETWEEN THE AFX AND THE STRAIGHT STENT GRAFT WAS SUSPECTED, ADDITIONAL 11MM STRAIGHT BYPASS GRAFT WAS IMPLANTED. FOR ANALYSIS, A PIECE OF THE GRAFT WAS TAKEN FROM THE AREA WHERE LEAKAGE OCCURRED. NO FURTHER DEVICE INFORMATION HAS BEEN RECEIVED OTHER THAN IT WAS A 18X09MM BIFURCATE GELSEAL GRAFT.

Additional Manufacturer Narrative

METHOD: 3287 - ELECTRON MICROSCOPY - RETURNED SAMPLES OF THE GRAFT WERE INSPECTED AND IMAGED UNDER SCANNING ELECTRON MICROSCOPE (SEM). RESULT: 3199 - INCOMPLETE DEVICE RETURNED - 4 VERY SMALL GRAFT SAMPLES WERE RETURNED. 213 - NO FAILURE DETECTED - SEM INSPECTION DID NOT SHOW ANY DAMAGE OR HOLES IN THE MATERIAL. CONCLUSION: 10 - CANNOT COMPLETE INVESTIGATION, INCOMPLETE DEVICE RETURNED. FOUR SMALL PIECES OF THE GRAFT WERE RETURNED TO VASCUTEK FOR ANALYSIS. 16MM AND 20MM SAMPLES WERE EXAMINED UNDER SCANNING ELECTRON MICROSCOPE (SEM). IMAGES WERE TAKEN OF THE OUTSIDE AND INSIDE STRUCTURE OF THE SURFACE. THERE WAS NO DAMAGE OR HOLES FOUND ON THE MATERIAL. DUE TO VERY SMALL SAMPLE SIZES VASCUTEK COULD NOT CARRY OUT ANY ADDITIONAL TESTING. FURTHER ACTION IS NOT PLANNED; HOWEVER, THE ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ON-GOING COMPLAINT TRENDING AND REPORTING PROCESS AND IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME. VASCUTEK CONSIDER THIS CASE CLOSED.

Description of Event or Problem

THIS REPORT IS BEING SUBMITTED AS FOLLOW UP # 1 FOR MFG. REPORT # (B)(4) TO PROVIDE ADDITIONAL INFORMATION REGARDING RETURNED SAMPLES ANALYSIS RESULTS.