The catalog number identified in section has not been cleared in the u.S.But is similar to the fluency plus endovascular stent graft that are cleared in the u.S.The pro code and 510 k number for the fluency plus endovascular stent graft are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 11/2023) the information provided by bd represents all of 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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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: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.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.Based on the investigation performed in the laboratory, the stent graft was found partially deployed and stuck inside the sheath.The marker band was found deformed and is considered as a cascading event of the partial deployment.Based on the investigation of the provided information, the investigation is confirmed for partial deployment of the stent graft and the subsequent deformation of the marker band.The system was flushed, and appropriate introducer sheath and guidewire were used.Additionally, it is known that the proximal end of the stent graft was placed in a straight section of the lumen prior to deployment.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.Regarding preparation of the device the instructions for use state 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 instructions 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 instructions 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'; the packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.H10: d4 (expiry date: 11/2023).H11:section a through f - the information provided by bd represents all of 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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