It was reported that during a stent graft placement procedure for stenosis declot in dialysis graft, only the first couple of struts were allegedly deployed.It was further reported that at one point resistance was felt on the wheel and it was not deploying correctly.Reportedly, the stent was removed from the patient.There was no reported patient injury.
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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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the delivery system was returned for evaluation, and the force transmitting proximal sheath was broken which indicates high tensile forces were experienced during deployment.Though the stent was returned completely deployed, it is thought that this happened post the reported event since the catheter was still inside the introducer.It is considered the break of the proximal sheath led to the impossibility to completely deploy the stent which leads to confirmed results for break and misfire.It was reported that there was no calcification/tortuosity but the lesion was not pre-dilated.Based on evaluation of the sample, the investigation is closed with confirmed results for break and misfire.A definite root cause could not be established.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instruction for use state: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated", and "0.035 inch guidewire of appropriate length (.), introducer sheath with appropriate inner diameter" should be used; the packaging pictogram indicates the use of an 8f introducer.Holding and handling of the system throughout deployment was found sufficiently described.H10: d4 (expiry date: 08/2024).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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It was reported that during a stent graft placement procedure for stenosis declot in dialysis graft, only the first couple of struts were allegedly deployed.It was further reported that at one point resistance was felt on the wheel and it was not deploying correctly.Reportedly, the stent was removed from the patient.There was no reported patient injury.
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