Manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the sample was returned for evaluation.The returned sample was contaminated and outer sheath was fractured on the proximal.The stent graft was partially deployed.Elongation at the fracture site indicated high release force.The system was flushed and the right accessories were used but the introducer was removed for sheathless procedure.Additionally the system should be straightened prior to deployment and the proximal end of the stent graft should be placed in a straight section of the lumen prior to deployment.In this case these steps were reportedly followed.Based on the provided information the investigation is closed with a confirmation for partial deployment and sheath fracture.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.The instructions for use state: 'if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device.' regarding preparation of the device the instructions for use state that 'prior to loading the endovascular 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 instructions for use state: 'prior to stent graft deployment, ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible endovascular system failure.' regarding accessories the instructions for use states: 'prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location.The use of an appropriately sized introducer sheath is recommended.'; the packaging pictograms indicate an introducer size of 9f and a 0.035" guidewire.Expiry date: 01/2025.
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