Catalog Number ZVM12040 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The catalog number identified 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.As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 11/2023).
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Event Description
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It was reported that during stent placement, small piece of plastic allegedly broke inside the patient.There was no reported patient injury.
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Event Description
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It was reported that during stent placement small piece of plastic allegedly broken inside of the patient.It was further reported that the plastic portion allegedly detached from the device.There was no reported patient injury.
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Manufacturer Narrative
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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 stent delivery system was returned for evaluation.Based on the sample returned no defect could be found.No segment of the stent delivery system was missing.It is reasonably considered that the reported issue is due to a misinterpretation of the design of the delivery system after deployment.In this case it could be confirmed that the delivery system returned was undamaged and no segments of the delivery system were missing.Based on the information available and the evaluation of the sample the reported issue could not be confirmed.The reported issue was caused by misinterpretation of the design of the delivery system after deployment.Labeling review: in reviewing the instructions for use supplied with this product the potential issue was found addressed.The instructions for use states: "after stent deployment, carefully withdraw the delivery system from the patient over the guidewire.After removing the delivery system, visually confirm that the entire stent delivery system has been removed.(a) inner catheter (b) outer catheter (c) moving distal marker (c) on outer catheter.A sketch displaying the design of the distal segment of the delivery system post stent deployment.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: b5, d4 (expiry date: 11/2023), g3.H11: h6 (method, result, conclusion).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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Search Alerts/Recalls
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