H10: manufacturing review: 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 stent graft delivery system sample was not returned for evaluation and photos were not provided which leads to inconclusive result.It was reported that a 0.035 guidewire was in use, the procedure was performed bareback, neither tortuosity nor calcification were reported in the tracking vessel, the lesion was pre-dilated, the device was flushed prior to use and the proximal end of the stent graft was placed in a straight section of the vessel prior to deployment attempts.Based on the available information and as the sample was not returned for evaluation, the investigation is closed with inconclusive results 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.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 the use of an 10f introducer.H10: d4 (expiration date: 08/2025) h11: section a through f ¿ the information provided by bd represents all 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.H3 other text : device not returned.
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It was reported that during a stent placement procedure via the right cephalic vein, the stent allegedly partially deployed.It was further reported that the partially opened stent was removed from the patient.Reportedly, the procedure was completed using another device.There was no reported patient injury.
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