Manufacturer narrative: investigation findings: 213 - no device problem found - the section of returned sample was porosity tested which gave a result of 181ml/min.Specification states max limit is 515ml/min., a sem analysis was performed on the 28 nov 22, this showed the weave of the fabric was uniform and had no abnormality in the structure of the fabric which could have caused the reported leakage., a textile review was performed on the sample which confirmed the graft size and that the weave was tight showing no defects.Investigation conclusion : 67 - no problem detected - review of manufacturing records showed the device was manufactured to specification,, analysis of returned section of graft gave results within specified parameters therefore no problem was confirmed.4315 - cause not established - the root cause of the event could not be determined.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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