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.Investigation summary: the sample was returned for evaluation.The returned catheter sample was found in used condition without covered stent, and fully functioning so that the reported expansion failure of the stent could not be confirmed.Even though the sample was returned and the stent was not found loaded, no pictures or x-ray images were provided for evaluation, and the issue could not be verified.Based on the information available the investigation is inconclusive for expansion failures of the stent.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: 'special care must be taken to ensure that an appropriately sized device is selected.In the case of a diameter difference between the inflow and the outflow end, utilize the following as the reference vessel depending on the type of access.For an av graft access, utilize the graft diameter and for an av fistula access, utilize the inflow vein diameter.' a covered stent diameter selection table is part of the instructions for use demonstrating the relationship between covered stent diameter, and recommended oversizing.Regarding preparation the instructions for use states: 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated.', and 'post dilate the covered stent with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel.' under covered stent specific events that could be associated with clinical complications the ifu mention: '(¿), compression, kinking and insufficient covered stent expansion' h10: d4 (expiry date: 11/2023), g3.H11: b5, h6 (device, result, conclusion).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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