The catalog number identified has not been cleared in the us, but is similar to the lifestent 5f vascular stent products that are cleared in the us.The pro code and 510k number for the lifestent 5f vascular stent products is identified in this report.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiry date: 03/2025.
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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 products that are cleared in the us.The pro code and 510k number for the lifestent 5f vascular stent products is 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 sample was returned for evaluation.The returned sample was found in used condition without stent, and with broken inner catheter cardan tube.A short piece of the cardan tube was missing which reportedly was left inside patient.The investigation leads to confirmed result for inner catheter cardan tube break and detachment.An indication for a process related issue could not be found.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.H10: (expiry date: 03/2025).H11: section a through f ¿ the information provide 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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