GELSOFT

Additional Manufacturer Narrative

OF NOTE : THIS COMPLAINT RELATES TO A GELSOFT BIFURCATE, CAT NO 631610 WHICH IS A SPECIAL DEVICE ( 16MM BODY AND 2 X 10MM LEGS) ONLY MARKETED AND APPROVED IN (B)(4). THIS IS A SIMILAR DEVICE TO A 631608 ( 16MM BODY, 2X 8MM LEGS) WHICH IS APPROVED IN USA AND THEREFORE DETERMINED TO BE A REPORTABLE EVENT. (B)(4). METHOD CODE - ACTUAL DEVICE NOT EVALUATED - STITCH ADDED TO CRUTCH OF DEVICE TO STOP LEAKAGE AND DEVICE REMAINED IMPLANTED. NO TESTING METHODS PERFORMED - DEVICE REMAINED IN SITU THEREFORE NO FURTHER TESTING OCCURED. PROCESS EVALUATION - A REVIEW OF MANUFACTURING AND QUALITY RECORDS WAS PERFORMED WITH PARTICULAR ATTENTION TO WHOLE GRAFT POROSITY TESTING OF DEVICE. MANUFACTURING REVIEW - A REVIEW OF MANUFACTURE OF DEVICE CARRIED OUT WITH PARTICULAR ATTENTION TO WHOLE GRAFT POROSITY TESTING OF DEVICE. STERILISATION PROCESS REVIEW - REVIEW OF THE STERILE CYCLE REPORT CARRIED OUT. RESULTS - NO FAILURE DETECTED - REVIEW OF QC, MANUFACTURING, PHYSICAL TESTING AND STERILISATION RECORDS SHOWED BATCH WAS MANUFACTURED TO SPECIFICATION. CONCLUSIONS - UNABLE TO CONFIRM COMPLAINT - REVIEW OF QC, MANUFACTURING AND PHYSICAL TESTING RECORDS SHOWED BATCH WAS MANUFACTURED TO SPECIFICATION. ALL PHYSICAL TESTING RESULTS WERE WELL WITHIN SPECIFICATION. STERILISATION CYCLE WAS COMPLETED WITHOUT ISSUE. DEVICE NOT RETURNED - DEVICE REMAINS IMPLANTED THEREFORE NO FURTHER INVESTIGATION WAS POSSIBLE. AN INVESTIGATION WAS COMPLETED WHICH SHOWED NO ISSUES OR ADVERSE TRENDS. THE REVIEW OF MANUFACTURING, QC, STERILITY AND PHYSICAL TESTING RECORDS SHOWED THAT THE GRAFT WAS MANUFACTURED TO SPECIFICATION. THE WHOLE GRAFT POROSITY RESULTS WERE WELL BELOW THE MAXIMUM LIMITS. A REVIEW OF SIMILAR REPORTED GELSOFT EVENTS GAVE A LOW OCCURRENCE RATE OF (B)(4). THERE HAVE BEEN NO SIMILAR EVENTS. REPORTED FOR UNITS OF THE SAME BATCH ((B)(4) UNITS IN BATCH). AS THE DEVICE REMAINS IN SITU WITHIN THE PATIENT, A PHYSICAL ANALYSIS IS NOT POSSIBLE. THE ROOT CAUSE OF THE EVENT WAS NOT IDENTIFIED. FURTHER ACTION IS NOT PLANNED, HOWEVER, THE ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ROUTINE COMPLAINTS MONITORING AND REPORTING PROCESS. IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME. VASCUTEK CONSIDER THIS CASE CLOSED.

Description of Event or Problem

EVENT WAS REPORTED ON (B)(4) 2017 TO VASCUTEK AS FOLLOWS: BLOOD LEAKAGE FROM THE CROTCH AREA OF Y SHAPE: AFTER THE PROXIMAL PART OF THE LIMB AND THE DISTAL END OF ONE BRANCH WERE ANASTOMOSED, WHEN THE DISTAL END OF ANOTHER BRANCH WAS DE-CLAMPED TO ANASTOMOSE, LEAKAGE WAS OBSERVED FROM THE CRUTCH AREA OF Y SHAPE. HEMOSTASIS WAS ACHIEVED BY SUTURING WITH A PROLENE 5-0. THE IMPLANT WAS SUCCESSFULLY COMPLETED. NO SERIOUS INJURY. OPERATION TYPE: ABDOMINAL VASCULAR PROSTHESIS REPLACEMENT SURGERY BLOOD LOSS: APPROXIMATELY 10 CC.