Catalog Number VENEM16120 |
Device Problem
Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The catalog number identified in section d4 has not been cleared in the us but is similar to the venovo venous stent system that are cleared in the us.The pro code and 510 k number for the venovo venous stent system are identified in d2 and g4.A voluntary recall has been initiated for the venovo¿ venous stent system 9f which was product catalog/lot number specific.Reportedly the proximal end of the stent does not immediately expand upon deployment.The proximal end of the stent remains connected to the delivery system.As a result of the field action, this event is being reported as a malfunction reportable event.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.(expiration date: 08/2024).Device not returned.
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Event Description
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It was reported that during a stent placement procedure, when deploying the stent, last part allegedly got stuck on the inner catheter.There was no reported patient injury.
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Event Description
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It was reported that during a stent placement procedure, when deploying the stent, last part allegedly got stuck on the inner catheter.There was no reported patient injury.
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Manufacturer Narrative
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H10: a voluntary recall has been initiated for the venovo¿ venous stent system 9f which was product catalog/lot number specific.Reportedly the proximal end of the stent does not immediately expand upon deployment.The proximal end of the stent remains connected to the delivery system.As a result of the field action, this event is being reported as a malfunction reportable event.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the venovo venous stent system that are cleared in the us.The pro code and 510 k number for the venovo venous stent system 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 sample was not returned for evaluation and no image/ x-ray were provided for review.Therefore the investigation leads to inconclusive evaluation result.Based on the information available the investigation is closed with inconclusive result for stent expansion issue.A definite root cause for the reported event could not be determined.Labeling review: a review of the relevant instructions for use for this product was conducted.The instructions for use was found to address potential worst case complications and adverse events potentially related to expansion issue such as incorrect positioning of the stent requiring further stenting or surgery, intimal injury, stent fracture, and misplacement.H10: d4 (expiration date: 08/2024), g3 h11: h6 (method) 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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Search Alerts/Recalls
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