H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the e-luminexx vascular stent that are cleared in the us.The pro code and 510 k number for the e-luminexx vascular stent 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 not available for evaluation and no photos were provided for review.Based on the information available and as the sample was not provided for evaluation, the investigation is closed with inconclusive result.A definite root cause of the reported incident cannot be identified.Labeling review: relevant labeling supplied with this product was reviewed.The reported issue and potential factors were found addressed.E.G., the instructions for use states: "visually inspect the 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 precautions, the instructions for use states: "take care to avoid unnecessary handling, which may kink or damage the delivery system.Do not use if device is kinked".Regarding general warnings, the instructions 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".Regarding accessories the instructions for use states: "in addition to the e-luminexx¿ vascular stent, the following standard materials may also be required to facilitate delivery and deployment of the e-luminexx¿ vascular stent: 8 f (2.67 mm) or larger guiding catheter or 6 f (2.0 mm) or larger introducer sheath; 0.035 inch (0.89 mm) diameter guidewire".H10: d4 (expiration date: 10/2026).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.H3 other text : device not returned.
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