GELSOFT

Additional Manufacturer Narrative

(B)(4). A REVIEW OF THE RETAINED MANUFACTURING AND QUALITY RECORDS (WITH SPECIFIC EMPHASIS OF THE BASE MATERIAL PERMEABILITY AND DEVICE POROSITY TESTING) CONFIRMED THAT THE PRODUCT WAS MANUFACTURED TO THE INTENDED SPECIFICATIONS. THE WHOLE BATCH OF (B)(4) PASSED POROSITY TESTING WELL BELOW ACCEPTANCE LIMIT OF 152ML/MIN WITH MINIMUM READING OF 23ML/MIN AND HIGHEST READING OF 28ML/MIN. A REVIEW OF SIMILAR EVENTS WAS PERFORMED FOR ALL KNITTED DEVICES THAT HAVE BEEN REPORTED TO HAVE LEAKED. THE INCIDENT RATE FOR REPORTED LEAKAGE EVENTS WAS CONFIRMED AS 0.019% (COMPLAINTS V SALES). THE REVIEW INCLUDED ALL SIMILAR EVENTS REPORTED TO VASCUTEK BETWEEN JAN2013 - SEP 2018 INCLUSIVE. NO NEGATIVE TREND WAS IDENTIFIED DURING THE REVIEW.

Description of Event or Problem

VASCUTEK LTD WAS NOTIFIED OF AN EVENT THAT OCCURRED IN (B)(6), THE EVENT WAS DESCRIBED AS FOLLOWS: ON (B)(6) 2017: THE GRAFT WAS IMPLANTED FOR ABDOMINAL AORTIC ANEURYSM (AAA). ON (B)(6) 2018: THE PATIENT VISITED THE HOSPITAL COMPLAINING ABOUT PAIN. THE DEPARTMENTS OF CARDIOVASCULAR SURGERY AND RADIOLOGY IDENTIFIED BLOOD LEAKAGE FROM THE LEFTMOST ONE OF THE GELSOFT BRANCHES BY CT SCANNING. A STENT GRAFT WAS THEN ADDED TO THE LEAKAGE AREA.

Additional Manufacturer Narrative

THE DISTRIBUTOR INFORMED VASCUTEK THAT THE DEVICE WOULD NOT BE MADE AVAILABLE AS IT REMAINS IN SITU WITHIN THE PATIENT'S ANATOMY, THEREFORE NO ANALYSIS OF THE DEVICE IS POSSIBLE. AS FURTHER DEVICE ANALYSIS IS NOT POSSIBLE, AND GRAFT MET ALL ACCEPTANCE CRITERIA DURING TESTING, VASCUTEK LTD CONSIDER THIS EVENT CLOSED. FURTHER ACTION IS NOT PLANNED; HOWEVER, THE ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ON-GOING COMPLAINTS TRENDING AND REPORTING PROCESS AND IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME.

Description of Event or Problem

THIS REPORT IS BEING SUBMITTER AS FOLLOW UP#1 FOR MFR. REPORT # 9612515-2018-00020 TO PROVIDE CLOSURE INFORMATION FOR THE CASE.