Model Number VENUM16120 |
Device Problem
Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a stent placement procedure in superior venacava brachiocephalic lesion site via left femoral vein approach, the stent was deployed fine with no issues until the last ten percent and it was allegedly adhered to the pad.It was further reported that when stent handle was rotated, the stent deployed off from the catheter.There was no reported patient injury.
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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 device has not been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.Expiration date: (expiration date: 08/2024).Device not returned.
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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.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 available for evaluation.One provided x-ray image demonstrates the deployed stent being held by the inner catheter; the single image does not indicate a time period, so that a clear statement regarding the stent holding process by the inner catheter is not possible.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 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, and malposition.D4 (expiry date: 08/2024), g3.H6 (method, result, conclusion).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 superior vena cava brachiocephalic lesion site via left femoral vein approach, the stent was deployed fine with no issues until the last ten percent and it was allegedly adhered to the pad.It was further reported that when stent handle was rotated, the stent deployed off from the catheter.There was no reported patient injury.
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Search Alerts/Recalls
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