Catalog Number FVL14100 |
Device Problems
Break (1069); Positioning Failure (1158); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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 that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft are identified in d2 and g4.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 sampling is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 04/2025).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 pending return.
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Event Description
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It was reported that during a stent graft placement procedure in the aortoiliac artery via the right femoral artery access, the stent allegedly stopped deploying from the distal end.Reportedly, break in the system was allegedly observed at the proximal end.There was no reported patient injury.
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Event Description
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It was reported that during a stent graft placement procedure in the aortoiliac artery via the right femoral artery access, the stent allegedly stopped deploying from the distal end.Reportedly, break in the system was allegedly observed at the proximal end.There was no reported patient injury.
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Manufacturer Narrative
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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 that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft are identified in d2 and g4.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 stent graft delivery system was not returned for evaluation.A provided photo shows the outer sheath fractured which leads to confirmed results for sheath fracture.Deployment failure can't be confirmed based on the image.There was no indication for any manufacturing deficiencies.It was reported that it was an open surgical access, a 0.035" wire was in use, the tracking vessel was straight and not calcified, pre-dilation was not performed and the device was properly flushed before use.Based on evaluation of the provided photo, the investigation is closed with confirmed results for sheath fracture.Based on information available a definite root cause for the reported issue could not be determined.The intended use of the device to treat aneurysm represents off-label use.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding tortuous anatomy the instruction for use states "prior to stent graft deployment in tortuous anatomy, 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 preparation of the device the instruction for use states: "prior to loading the delivery system over a guide wire, both ports must be flushed with sterile saline to eliminate any air bubbles that may be trapped in the inner catheter lumen and/or the stent graft lumen.Flushing these lumens will also facilitate stent graft deployment.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.The instruction for use states that "the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established".H10: d4 (expiration date: 04/2025), 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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Search Alerts/Recalls
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