Catalog Number FVL07060 |
Device Problems
Positioning Failure (1158); Misfire (2532); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/29/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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.As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, a photo and images were provided for review.The investigation of the reported event is currently underway.(expiry date: 05/2022).
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Event Description
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It was reported that during a stent placement procedure through abdominal aorta, the outer sheath of the stent allegedly failed to deploy.It was further reported that the stent was removed.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: 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.The submitted medical images show two deployed stents in what appear to be the iliac arteries.Another image shows the distal end of the delivery system with the stent fully loaded.There is no evidence for a partial deployment.In this case the correct accessories were used and the proximal end of the stent graft was reportedly placed in a straight section of the lumen prior to deployment.Based on the provided information the investigation is confirmation for failure to deploy.The reported use of the device to treat aneurysm 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 states 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 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 8f and a 0.035" guidewire.It also contains the following precaution: 'the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established'.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.
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Event Description
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It was reported that during a stent placement procedure through abdominal aorta via brachial artery, the outer sheath of the stent allegedly failed to deploy.It was further reported that the stent was removed and the procedure was completed using spring coil plug.There was no reported patient injury.
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Search Alerts/Recalls
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