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Health effect: clinical code: (b)(4): no clinical signs, symptoms or conditions - no health consequences for the patient.Health effect: impact code (b)(4): no health consequences or impact - no patient harm or consequence - leak suture during procedure.No significant blood loss or delay to procedure.Medical device problem code: (b)(4): material integrity problem: site reported hole at bifurcation appeared during procedure.(b)(4): material perforation: hole reported at bifurcation of device.(b)(4): material puncture / hole: site reported hole in device at bifurcation.Component code - 4755 - term not applicable - the gelsoft plus bifurcate is manufactured from a single woven tube and does not contain any additional parts or subassemblies.Type of investigation (b)(4): analysis of production records: a review of qc, manufacturing and physical testing of base material was performed with particular attention to porosity testing and found no issue with the qc, manufacture or tests performed on batch.All whole graft porosity testing met acceptance criteria with no failures in batch.(b)(4): device not accessible for testing - device remains in situ and was not explanted.(b)(4): communication / interviews.Further information was provided by site: graft was not clamped in area of leakage, no excessive manipulation of graft and patient had no coagulation or blood disorders.It was reported that the graft was not pre-soaked prior to procedure for 5 minutes in saline or any other solution prior to procedure as recommended by ifu to improve handling and to make device less susceptible to leakage.(b)(4): trend analysis: a review of similar events for gelsoft / gelsoft plus gave an occurrence rate of 0.014% (complaint v sales).No reports of leakage were received for any of the remaining grafts from this batch of 10 devices at this time.Investigation findings: (b)(4): no device problem found: no issue was found with the review of batch records that could have resulted in leakage reported.Investigation conclusion: (b)(4): no problem detected: no issue was found with manufacture qc or physical testing of batch.(b)(4): unintended use error caused or contributed to event: the device was not pre-soaked as per ifu recommendation prior to use and this may have contributed to the event.As no device will be returned for further investigation as it remains implanted vascutek ltd now considers this complaint 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.
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