(b)(4).Review of the retained manufacturing and quality records (with specific emphasis of the base material permeability and device porosity testing) confirmed that the product was manufactured to the intended specifications.The whole batch of 3 passed porosity testing well below acceptance limit of 132ml/min with minimum reading of 25ml/min and highest reading of 30ml/min.A review of similar events was performed for all knitted devices that have been reported to have leaked.The incident rate for reported leakage events was confirmed as 0.021% (complaints v sales).The review included all similar events reported to (b)(4) between (b)(6) 2013 - (b)(6) 2018 inclusive.No negative trend was identified during the review.The distributor informed (b)(4) that the device would not be made available for further investigation, therefore no analysis of the device is possible.As further device analysis is not possible, and graft met all acceptance criteria during testing, (b)(4) consider this event closed.
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The event was reported as follows: the graft was leaking severely when checked before implantation.After tunnelling the graft under the skin, washing of the graft with saline was performed, in order to verify its position.An immediate and severe leak was observed at the bifurcation point.The graft was taken out and gore graft was used instead.
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