Incomplete device returned - the sample returned from the site was incomplete.The returned decontaminated sample was too small and had been cut along its length (approx.15mm of a 60cm graft) therefore no viable testing of material or support could be performed.No finding available - vascutek could not perform a batch review as no batch details were supplied and no viable testing could be performed on returned sample therefore no findings could be derived from information received cause not established - as no testing could be performed on returned sample vascutek could not establish a root cause of the reported event.Vascutek was also informed that no further device information could be supplied therefore no review of batch qc and manufacturing records could be performed.As this device was implanted in 2006 and shelf life is five years this device could not have been manufactured prior to 2001.A review of vascutek complaint database from 2000 to present date only showed 1 additional complaint for this catalogue number 670006 in 2007, however this was not for the same failure mode.No further complaints for this catalogue number have been received for this failure mode to date.Vascutek could not determine a root cause for this event.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.As no further information will be supplied and no testing could be performed on returned sample vascutek now considers this complaint closed.(b)(4).
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