Catalog Number FVL14120 |
Device Problems
Break (1069); Positioning Failure (1158); Difficult to Remove (1528); Failure to Advance (2524)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/05/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 08/2024).
|
|
Event Description
|
It was reported that during a stent graft placement procedure in the superior vena cava via right femoral vein, the stent graft allegedly failed to deploy.It was further reported that there was slight damage noted on the delivery system.Reportedly, the stent and the delivery system were removed as a single unit.The procedure was completed using another device.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products 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 returned for evaluation.It was contaminated and the the outer sheath showed signs of heavy elongation.The stent graft was fully loaded.Flushing was successful through the rear port but there was resistance through the two way stopcock.The guidewire passed through the delivery system.The stent graft was unable to be deployed due to resistance.The system was flushed and the right accessories were used.The delivery system was straightened prior to deployment but the proximal end of the stent graft was not placed in a straight section of the lumen.Based on the provided information the investigation is closed with a confirmation for failure to deploy.The reported use of the device to treat the superior vena cava is an off-label use.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding preparation of the device the instructions for use state that 'prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment.' regarding the anatomy of the placement site the instructions for use states: 'prior to stent graft deployment (.), ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy.' regarding stent graft deployment the instructions for use states: 'during release of the stent graft, the entire length of the flexible deployment system should be kept as straight as possible.Regarding accessories the instructions for use states: 'a super stiff guide wire (0.035 in.) is advanced from a femoral artery puncture site.Use an introducer sheath for the implant procedure'; the packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.Regarding indications for use it states: 'for use in the iliac and femoral arteries¿.H10: d4 (expiry date: 08/2024).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 graft placement procedure in the superior vena cava via right femoral vein, the stent graft allegedly failed to deploy.It was further reported that there was slight damage noted on the delivery system.Reportedly, the stent and the delivery system were removed as a single unit.The procedure was completed using another device.There was no reported patient injury.
|
|
Event Description
|
It was reported that during a stent graft placement procedure in the superior vena cava via right femoral vein, the stent graft allegedly failed to deploy.It was further reported that there was slight damage noted on the delivery system.Reportedly, the stent and the delivery system were removed as a single unit.The procedure was completed using another device.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products 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 returned for evaluation.It was contaminated and the the outer sheath showed signs of heavy elongation.The stent graft was fully loaded.During testing, flushing was successful through the rear port but there was resistance through the two way stopcock.The guidewire passed through the delivery system.The stent graft was unable to be deployed due to resistance.The system was flushed and the right accessories were used.Additionally the system should be straightened prior to deployment and the proximal end of the stent graft should be placed in a straight section of the lumen prior to deployment.In this case the delivery system was straightened prior to deployment but the proximal end of the stent graft was not placed in a straight section of the lumen.Based on the provided information the investigation is closed with a confirmation for failure to deploy.The reported use of the device to treat the superior vena cava is an off-label use.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding preparation of the device the instructions for use state that 'prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment.' regarding the anatomy of the placement site the instructions for use states: 'prior to stent graft deployment (.), ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy.' regarding stent graft deployment the instructions for use states: 'during release of the stent graft, the entire length of the flexible deployment system should be kept as straight as possible.Regarding accessories the instructions for use states: 'a super stiff guide wire (0.035 in.) is advanced from a femoral artery puncture site.Use an introducer sheath for the implant procedure'; the packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.Regarding indications for use it states: 'for use in the iliac and femoral arteries¿.H10: d4 (expiry date: 08/2024), g3, h6 (device) 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 : see h10.
|
|
Manufacturer Narrative
|
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products 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: it was contaminated and the the outer sheath showed signs of heavy elongation.The stent graft was fully loaded.During testing, flushing was successful through the rear port but there was resistance through the two way stopcock.The guidewire passed through the delivery system.The stent graft was unable to be deployed due to resistance.The vessel was reportedly neither calcified nor torturous.The system was flushed and the right accessories were used.Additionally the system should be straightened prior to deployment and the proximal end of the stent graft should be placed in a straight section of the lumen prior to deployment.In this case the delivery system was straightened prior to deployment but the proximal end of the stent graft was not placed in a straight section of the lumen.Based on the provided information the investigation is closed with a confirmation for failure to deploy.The reported use of the device to treat the superior vena cava is an off-label use.Based upon the available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding preparation of the device the instructions for use state that 'prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment.' regarding the anatomy of the placement site the instructions for use states: 'prior to stent graft deployment (.), ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy.' regarding stent graft deployment the instructions for use states: 'during release of the stent graft, the entire length of the flexible deployment system should be kept as straight as possible.Regarding accessories the instructions for use states: 'a super stiff guide wire (0.035 in.) is advanced from a femoral artery puncture site.Use an introducer sheath for the implant procedure'; the packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.Regarding indications for use it states: 'for use in the iliac and femoral arteries¿.H10: (expiry date: 08/2024).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 graft placement procedure in the superior vena cava via right femoral vein, the stent graft allegedly failed to deploy.It was further reported that there was slight damage noted on the delivery system.It was also reported that the stent allegedly had difficulty inserting and removing from the delivery system.Reportedly, the stent and the delivery system were removed as a single unit.The procedure was completed using another device.There was no reported patient injury.
|
|
Search Alerts/Recalls
|