The catalog number identified has not been cleared in the us but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified in common device name and pma/510k.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 for evaluation.The investigation of the reported event is currently underway.(expiry date: 08/2024).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 products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified in d2 and g4.H10: 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 physical sample was returned for evaluation.Based on the investigation performed in the laboratory, the fracture of the outer sheath was identified as the main issue, which led to the partial deployment of the stent graft.The system was flushed and appropriate introducer sheath and guidewire were used.The tissue was not calcified or tortuous in nature.Additionally, it is known that the proximal end of the stent graft was placed in a straight section of the lumen prior to deployment.The device was used in the portal vein, which represents an off-label use.Based on the investigation of the provided information, the investigation is confirmed for fracture of the outer sheath and subsequent partial deployment.A definite root cause for the reported event could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding the precautions upon unpackaging of the device, the instructions for use state: 'the sterile packaging and devices should be inspected prior to use.Verify that the packaging and the device are undamaged and that the sterile barrier is intact.If damaged, do not use' 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 9f and a 0.035" guidewire.Regarding the indications the instructions for use states 'for use in the iliac and femoral arteries'.H10: d4 (expiry date: 08/2024), g3.H11: b5, h6 (device, result, conclusion).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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