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 physical sample was returned for evaluation.The returned sample was an uncontaminated device with an outer sheath fracture near the proximal end.The stent graft was fully loaded.The investigation is confirmation of fracture.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Under 'directions for use' it states :"carefully remove the endovascular system from its packaging and inspect packaging and system for any damage or defects.Do not use if the sterile barrier is compromised." h10: d4(expiry date: 01/2025), h11: h6 (method, 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.H3 other text : see h10.
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