No known impact or consequence to patient: no reported significant delay to procedure, patient consequence or harm.Bleeding was halted with application of suture and patient reported as stable post op.Material integrity problem.Material puncture / hole : reported as leakage from hole in the body of the graft.Historical data analysis: a 5-year review of previous gelweave complaints for hole in the graft was carried out and gave an occurrence rate of 0.003%.Analysis of production records: review of retained qc, manufacturing and physical testing records performed: a review of retained qc and manufacturing records showed that this batch was manufactured to specification with no issues raised.A review of the graft base material physical tests showed all testing met acceptance criteria.Base material porosity tests and finished product porosity tests were all within specification with no issues highlighted.Device not accessible for testing: device remains implanted in patient and will not be returned for testing.No device problem found: review of product batch records showed no issue with the manufacture of this batch.Cause not established - cause of the leakage could not be established from review of qc and manufacturing records.Vascutek ltd.Is submitting this report as an initial/final report.No further information available and no investigation is possible as device remains implanted.Vascutek ltd.Now considers this complaint closed 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.
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