H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4.(expiration date: 02/2026).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.
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It was reported that during a stent placement procedure, the red release button allegedly fell out of the device.It was further reported that the stent release was allegedly not possible.Reportedly, none of the thumb wheels turned.There was no reported patient injury.
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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 vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent are identified in d2 and g4.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 sample was returned for evaluation and the outer part of the safety lock slider was found separated from the inner part of the safety slider at the welding joint.The investigation leads to confirmed result for failure of the safety slider welding joint.Therefore, based on the investigation of the provided information, the investigation is closed as confirmed for separation of the safety slider at the welding joint.The root cause was determined to be manufacturing related.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instruction for use state: 'unlock the safety lock slider by pulling it back towards the wheels from the locked position into the unlocked position.Ensure that the red safety lock slider is completely pulled back.', and 'examine the stent system to ensure it has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.If it is suspected that the sterility or performance of the stent system has been compromised, the device should not be used.Verify that the safety lock slider is still in the locked position'.H10: d4 (expiration date: 02/2026), g3, h6 (device).H11: h6 (method, result, conclusion).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 : see h10.
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It was reported that during a stent placement procedure, the red release button allegedly fell out of the device.It was further reported that the stent release was allegedly not possible.Reportedly, none of the thumb wheels turned.There was no reported patient injury.
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