H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft are identified in d2 and g4.H10: manufacturing review: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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 stent graft was found partially deployed and the outer sheath was fractured which leads to confirmed results.Also, photos of the complaint sample were provided which show the outer sheath fractured and the stent graft partially deployed.It was reported that an 8f introducer was used for access, the tracking vessel was neither tortuous nor calcified, the lesion was not predilated and the device was flushed prior to use.Based on evaluation of the device sample returned, the investigation is closed with confirmed results for sheath fracture and partial deployment.Based on information available a definite root cause for the reported issue could not be determined.The intended placement of the device to treat femoral artery occlusion represents off-label use.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding precautions, the instructions for use states "if excessive force is felt during stent graft deployment, do not force the delivery system.Remove the delivery system and replace with a new unit".Regarding preparation of the device the ifu states: the instructions for use states: "prior to loading the delivery system over a guide wire, both ports must be flushed with sterile saline to eliminate any air bubbles that may be trapped in the inner catheter lumen and/or the stent graft lumen.Flushing these lumens will also facilitate stent graft deployment.A super stiff guide wire (0.035 in.) is advanced from a femoral artery puncture site.Use an introducer sheath for the implant procedure".The packaging pictograms indicate an introducer size of 8f and a 0.035" guidewire.The instructions for use states, "pre-dilatation of the stenotic lesion may be performed prior to stent graft deployment at the discretion of the treating physician".With regards to indications for use, the instructions for use states "the fluency plus vascular stent graft is indicated for the treatment of atherosclerotic lesions in the iliac arteries".H10: d4 (expiration date: 07/2025).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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