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 stent delivery system was returned for evaluation; the delivery system outer sheath was fractured, and the stent graft was found partially deployed which leads to confirmed results.It was reported that an 8f introducer was used, the vessel was calcified, the device was flushed and pre-dilation was performed.The two way stopcock was detached and missing but this was considered not to be related to the reported event and probably happened post the reported incident.Based on the provided information and the evaluation of the returned sample, the investigation is confirmed for fracture and partial deployment.A definite root cause for the reported event could not be determined.Labeling review: the relevant labeling of this product was reviewed.Regarding preparation of the device the instruction for use 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 instruction for use 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." regarding accessories the instruction for use states: "a super stiff guide wire (0.035 in.) is advanced from a femoral artery puncture site.Use an introducer sheath for the implant procedure" and the packaging pictograms indicate an introducer size of 8f and a 0.035" guidewire.H10: d4 (expiration date: 12/2024).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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