Manufacturing review: manufacturing record review was not performed, as the information available does not reasonably suggest a manufacturing process may have caused or contributed to the reported event.Investigation summary: a stent graft delivery system was returned.Based on the evaluation of the returned sample the reported issue was confirmed.The stent graft was found not deployed and a strut of the stent graft was found perforating the distal end of the outer sheath, which made stent graft deployment impossible.No indication was found for manufacturing related issues.As a result of the investigation performed the complaint is confirmed.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the current labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device the ifu states that "prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment." regarding the anatomy of the placement site the ifu states: "prior to stent graft deployment (.), ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy." additional narrative: date received by mfr.Corrected data: device evaluated by mfr, evaluation codes (results, conclusion).
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