The catalog number identified in catalog # has not been cleared in the us but is similar to the lifestent 5f vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent are identified in common device name and pma/510k.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2025).
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent 5f vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent are identified in d2 and g4.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.The returned catheter sample was found in used/ deployed condition without stent, and the inner catheter cardan tube was found broken twice at the distal end, and at the proximal end which leads to confirmed result for inner catheter break.A process related issue could not be found.One x-ray image was provided but an inner catheter break and detachment inside the vessel could not be identified due to poor resolution.The vessel was very calcified so that friction was felt, and the lesion was pre dilated; the system was correctly held at the stability sheath and difficulty was not experienced during deployment; the guidewire was running smoothly inside the system, and a force increase indicating entrapment was not felt.6f introducer and 0.035" guidewire were used for access.Based on the information available the investigation is closed with confirmed result for inner catheter break.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use states: 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' regarding pre dilation the instructions for use states: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' under materials required the instructions for use states: '5f (1.67 mm) or larger introducer sheath; 0.014-inch (0.36 mm) - 0.035-inch (0.89 mm) diameter guidewire'.Regarding insertion and removal difficulty of the delivery system the instructions for use states: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' holding and handling of the system throughout deployment was found sufficiently described.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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