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 not available for evaluation.The stent graft remains implanted and photos of the alleged deformed stent were not provided for evaluation which leads to inconclusive results.It is only know that the stent graft was re-expanded after pta.Based on the provided information and as no images or videos were provided with the alleged failure, the investigation is closed with inconclusive results.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.Regarding precautions the instructions for use states: "prior to covered stent implantation refer to the sizing table and read the instructions for use.Careful attention should be paid to ensure the device is appropriately sized to the vessel diameter, taking into account any change in the vessel diameter that may have resulted from previous interventions.For an av graft access, utilize the graft diameter as the reference vessel and for an av fistula access, utilize the inflow vein diameter as the reference vessel." and "post dilation of the covered stent must be performed using an appropriately sized pta balloon catheter to avoid damage to the covered stent.The covered stent cannot be post dilated beyond its labeled diameter.The flared distal end does not require post dilation".The instructions for use equally further indicates that "kinking and insufficient covered stent expansion" may occur as complications.H10: b5, d4 (expiry date: 10/2023), g3.H11: h6 (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.
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