It was reported that during a stent graft placement procedure, the stent allegedly had an issue while deploying.It was further reported that the top outer blue braided portion pulled apart and separated losing the option for deployment with the push pull part.Reportedly, the stent got two to three centimeters deployed and then it would still stick in the sheath.There was no reported patient injury.
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It was reported that during a stent graft placement procedure, the stent allegedly had an issue while deploying.It was further reported that the top outer blue braided portion pulled apart and separated losing the option for deployment with the push pull part.Reportedly, the stent got two to three centimeters deployed and then it would still stick in the sheath.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.Investigation summary: the stent delivery system was returned for evaluation without the stent in the catheter as it seemed to have be normally deployed.The catheter had no elongation or break which leads to inconclusive results.A process related issue could not be identified.Based on the provided information and the evaluation of the returned sample, the investigation is inconclusive for break and 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.The instructions for use state: 'if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device.' 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: "prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location.The use of an appropriately sized introducer sheath is recommended".The packaging pictograms indicate an introducer size of 9f and a 0.035" guidewire.H10: d4 (expiry date: 07/2025), g3.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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