H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the e-luminexx vascular stent products that are cleared in the us.The pro code and 510 k number for the e-luminexx vascular stent products are identified in d2 and g4.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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the stent delivery system was returned for evaluation.The t-luer adapter was detached from the slider which made a successful deployment using the trigger impossible.The stent was still loaded in the delivery catheter and could be deployed during deployment test using the conventional method.Based on available information and evaluation of the returned sample, the investigation was closed with confirmed results for detachment and the subsequent failure to deploy using the trigger is considered as a cascading event.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 general warning, the instruction for use states "should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit" and "visually inspect the bard e-luminexx vascular stent to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment".Regarding accessories, the instruction for use states "the bard s.A.F.E.R 6f delivery system requires a minimum 8f guiding catheter or a minimum 6f introducer sheath" also "via the femoral route, insert a 0.035¿ (0.89 mm) guide wire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion".The packaging pictograms indicate an introducer size of 6f and a 0.035" guidewire.H10: d4 (expiry date: 09/2025).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.
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