Model Number VENUM16100 |
Device Problems
Break (1069); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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 is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.D4 (expiry date: 08/2024).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.Device pending return.
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Event Description
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It was reported that during a stent placement procedure in the left common iliac vein via left upper saphenous vein, the stent was allegedly unable to be deployed during the final steps of deployment.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 in the left common iliac vein via left upper saphenous vein, the stent was allegedly unable to be deployed during the final steps of deployment.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: 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 physical device was not returned for evaluation and no images were provided for review which leads to inconclusive evaluation result.Therefore, 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 malposition.H10: d4 (expiration date: 08/2024), g3 h11: h6 (method, result, conclusion) 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.
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Event Description
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It was reported that during a stent placement procedure in the left common iliac vein via left upper saphenous vein, the stent was allegedly unable to be deployed during the final steps of deployment.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: manufacturing review: 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 returned for evaluation.The condition of the returned delivery system confirms an expansion issue.The system was found in used condition without stent, and the stent brake of the inner catheter which was under the stent was found with significant imprints and damage on its surface; this is considered an indication that the stent adhered to the stent brake immediately after deployment.The proximal sheath was found broken distal to the grip which was considered a cascading issue.The investigation leads to confirmed result for stent expansion issue and break of the proximal sheath.Based on the information available the investigation is closed with confirmed result for stent expansion issue and cascading break of the proximal sheath.A definite root cause for the reported event could not be determined.Labeling review: a review of the relevant instruction for use for this product was conducted.The instruction 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 malposition.H10: d4 (expiration date: 08/2024), g3, h2, h6 (device) h11: e3, h6 (method, result) 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 : see h10.
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Search Alerts/Recalls
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