Catalog Number EX060403C |
Device Problem
Fracture (1260)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/19/2021 |
Event Type
Injury
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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 lifestent vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent 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: 02/2023).
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Event Description
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It was reported that during a stent procedure in the superficial femoral artery, the distal end of the stent allegedly fractured during insertion.Reportedly, the device was not removed.The current patient status is unknown.
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent are identified in d2 and g4.H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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 sample was not returned for evaluation and image was not provided.Therefore, the investigation is inconclusive for the reported issue.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.Holding and handling of the system throughout deployment was found sufficiently described; in particular the instruction for use state: 'deployment of the stent is complete when the proximal stent radiopaque markers appose the vessel wall and the sheath radiopaque zone is proximal to the proximal stent radiopaque markers.' the instruction for use further state: 'predilitation of the lesion should be performed using standard techniques.' h10: d4 (expiry date: 02/2023), g3.H11: h6 (method).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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Event Description
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It was reported that during a stent procedure in the superficial femoral artery the distal end of the stent allegedly fractured during insertion.Reportedly, the device was not removed.The current patient status is unknown.
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Search Alerts/Recalls
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