The catalog number identified has not been cleared in the us, but is similar to the lifestent vascular stent products that are cleared in the us.The pro code and 510k number for the lifestent vascular stent products is identified.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.The investigation of the reported event is currently underway.(expiry date: 08/2023).
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The catalog number identified in section d4 has not been cleared in the us, but is similar to the lifestent vascular stent products that are cleared in the us.The pro code and 510k number for the lifestent vascular stent products is identified in d2 and g4.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.Investigation summary: the sample was returned for evaluation.The returned sample was found without damage/ deformation indicating failure to cross the lesion; images/ dicom demonstrating failure to cross were not provided so that a failure to cross cannot be confirmed.The shipping lock was attached, and the stent was found prematurely deployed a few [mm] without flowering which may be a consequence of crossing failure but it was not known when the stent prematurely deployed.The investigation leads to confirmed result for premature deployment.The guidewire reportedly was running smoothly inside the system but the introducer size was not known; the lesion was pre dilated.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: 'if resistance is met during delivery system introduction, the system should be removed and another system should be used.' in regards to damage the instructions for use state: 'examine the stent and delivery system device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.', and 'visually inspect the distal end of the delivery system catheter to ensure that the stent is contained within the sheath.Do not use if the stent is partially deployed.' the instructions for use further state: 'gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035 inch (0.89 mm) diameter guidewire', d4 (expiry date: 08/2023).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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