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 physical sample was returned for evaluation.Based on the investigation performed in the laboratory, the detachment of the outer sheath could be identified, which is considered to be related to the reported failure to deploy the stent graft.Additionally, a deformation of the distal end of the catheter in the area of the marker band was identified.The system was flushed, and an appropriate guidewire was used.Based on the investigation of the provided information, the investigation is closed as confirmed for detachment of the outer sheath and the deformation of the distal end of the catheter in the area of the marker band.A definitive root cause 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 preparation of the device the instructions for use states ¿carefully remove the endovascular system from its packaging and inspect packaging and system for any damage or defects.Do not use if the sterile barrier is compromised', 'flush the stent graft lumen with sterile saline by using a small volume syringe (¿) close the stopcock when flushing is complete and remove the syringe from the luer port'.Regarding the precautions prior and during deployment the instructions for use states 'prior to stent graft deployment, ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of higher deployment forces and possible endovascular system failure¿, ¿higher deployment force may be encountered (¿) in tortuous anatomy¿, and '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.¿ the instructions for use states regarding the accessories 'the use of an appropriately sized introducer sheath is recommended; prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location' the packaging pictograms indicate an introducer size of 9f and a 0.035" guidewire.H10: d4 (expiry date: 04/2024), g3, h6 (device).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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