Model Number VENUM14160 |
Device Problem
Activation Failure (3270)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/08/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
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: 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.H10: d4 (expiry date: 01/2025) 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.H3 other text : device pending return.
|
|
Event Description
|
It was reported that during a stent placement procedure in external iliac vein via popliteal access, one of the leg of the stent allegedly failed to expand.It was further reported that the stent was able to expand after some maneuvers.There was no reported patient injury.
|
|
Manufacturer Narrative
|
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 sample was not returned for evaluation.Images were provided for review.Provided images demonstrates the deployed stent inside the vessel and the inner catheter is visibly adhering to the stent in the section of the inner catheter cushion on the right side.The investigation leads to confirmed result for stent expansion issue.Based on the information available the investigation is closed with confirmed 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, stent fracture, and malposition.H10: d4 (expiry date: 01/2025), g3 h11: h6 (method, result, conclusion) 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.
|
|
Event Description
|
It was reported that during a stent placement procedure in the external iliac vein via popliteal vein, one of the leg of the stent allegedly failed to expand.It was further reported that the stent was able to expand after some maneuvers.There was no reported patient injury.
|
|
Event Description
|
It was reported that during a stent placement procedure in the external iliac vein via popliteal vein, one of the leg of the stent allegedly failed to expand.It was further reported that the stent was able to expand after some maneuvers.There was no reported patient injury.
|
|
Manufacturer Narrative
|
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: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.H10: g3 h11: d4 (medical device lot number), h6 (method, result, conclusion) 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.
|
|
Search Alerts/Recalls
|
|