GELSOFT

Additional Manufacturer Narrative

(B)(4). THE REVIEW OF DEVICE HISTORY RECORDS AND QC RECORDS WAS NOT CARRIED OUT AS DEVICE DETAILS WERE NOT PROVIDED BY THE CUSTOMER. WITHOUT THE RETURN OF THE GRAFT FOR ANALYSIS VASCUTEK LTD ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THIS EVENT. HOWEVER, FROM A REVIEW OF CLINICAL PAPERS AND THE DEVICE IFU IT HAS BEEN NOTED THAT DILATATION IS A KNOWN AND EXPECTED COMPLICATION OF THIS TYPE OF PROCEDURE DUE TO THE KNITTED STRUCTURE OF THE GRAFT. THE PERCENTAGE OF DILATATION VARIES SIGNIFICANTLY THROUGHOUT LITERATURE. IN THE LAST FIVE YEARS FROM 2014 TO 2019 VASCUTEK LTD HAS RECEIVED A TOTAL OF 8 COMPLAINTS, FOR KNITTED GRAFTS WHERE DILATATION OF THE GRAFT HAS BEEN REPORTED AS AN ISSUE. SALES FOR THIS PERIOD AND GRAFT TYPE IS (B)(4) UNITS. THIS GIVES A VERY LOW INCIDENT RATE OF (B)(4). AS DILATATION OF KNITTED GRAFTS IS INHERENT AND EXPECTED THERE IS NO COMMON INDUSTRY INCIDENT RATE FOR COMPARISON. ON THIS BASIS VASCUTEK NOW CONSIDERS THIS COMPLAINT CLOSED. HOWEVER, THIS ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ROUTINE COMPLAINTS MONITORING AND REPORTING PROCESS. IF AN ADVERSE TREND DEVELOPS ACTIONS WILL BE TAKEN AT THAT TIME.

Description of Event or Problem

THE EVENT WAS INITIALLY REPORTED TO VASCUTEK LTD GLASGOW AS FOLLOWS: THE PATIENT RECEIVED 3 BIFURCATED GRAFTS CREATING A SO-CALLED OCTOPUS GRAFT. DURING CT FOLLOW UP THE PHYSICIAN OBSERVED AN INCREASE OF THE DIAMETER OF THE MAIN GRAFT BODY TO 34MM. THIS COMPLAINT IS RELATED TO COMPLAINTS (B)(4) (MFR # 9612515-2019-00009) AND (B)(4) (MFR # 9612515-2019-00010).