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: 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.A physical evaluation was performed.The metal rod was bent and it is not known how and when this happened.The outer sheath was elongated, the stent was partially deployed by about 10 mm.The lesion was predilated and it is also known that appropriate accessories were used during the procedure.Tip detachment was reported; however, during sample evaluation the reported issue was not found.Stent sheath fracture could not equally be confirmed but there was sheath elongation.Based on the information available, the investigation is closed with confirmed result for partial 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 stent deployment, the instructions for use states "if resistance is encountered removing the delivery system, it is recommended to remove the delivery system, introducer and guidewire as a single unit".Regarding preparation, "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.Continue until saline drips from the distal end of the delivery system".' 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.As a precaution, the instructions for use states "predilatation of the stenosis may be performed prior to stent graft deployment at the discretion of the physician".H10: (expiry date: 02/2023).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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