Catalog Number EX061703C |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/06/2021 |
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 xl vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent xl vascular stent products 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 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: 10/2021).Device not returned.
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Event Description
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It was reported that during a stent graft placement procedure, the device allegedly restricted the flow of contrast requiring covered stent implantation to exclude severe atherosclerotic plaque.The patient status was unknown.
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Event Description
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It was reported that during a stent graft placement procedure, the device allegedly restricted the flow of contrast requiring covered stent implantation to exclude severe atherosclerotic plaque.The patient status was 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 xl vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent xl vascular stent products 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 images were not provided for review.Based on the information available, the investigation is inconclusive for elastic stent recoil/ obstruction of flow.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use closely describes holding and handling of the system throughout deployment.In particular the instructions for use state: 'verify that the distal and proximal stent ends are distal and proximal to the target lesion.Confirm that the introducer sheath is secure and will not move during deployment.(¿) firmly hold the black system stability sheath throughout deployment.Note: do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.Initiate stent deployment by rotating the thumbwheel in the direction of the arrows, while holding the handle in a fixed position.' the instructions for use includes a stent size selection table describing the stent diameter versus the reference vessel diameter.In regards to pta the instructions for use state: 'predilation of the lesion should be performed using standard techniques.', and 'post stent expansion with a pta catheter is recommended.' h10: d4 (expiry date: 10/2021), g3.H11: h6 (method).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.
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Search Alerts/Recalls
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