GELSOFT

Additional Manufacturer Narrative

(B)(4). A REVIEW OF MANUFACTURING AND QC RECORDS CONFIRMED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. 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, WHICH OCCURRED IN (B)(6) WAS REPORTED TO VASCUTEK LTD AS FOLLOWS: THE PATIENT RECEIVED BIFURCATED GRAFT. DURING CT FOLLOW UP THE PHYSICIAN OBSERVED AN INCREASE OF THE DIAMETER OF THE MAIN GRAFT BODY TO 31MM.