H10: manufacturing review: the lot history record of this lot was 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 physical sample was not available.One image was provided demonstrating both stents; one stent was found without damage or deformation which was considered the stent for this complaint.The alleged issue could not be re produced which led to an inconclusive evaluation result.A definite root cause for the reported event could not be determined.Labeling review: a review of the relevant for this product was conducted.The instruction for use was found to address potential complications and adverse events such as incorrect positioning of the stent requiring further stenting or surgery, intimal injury, and malposition.H10: d4 (expiry date: 08/2022), g3.H11: h6 (device, result).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.H3 other text : device not returned.
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