Catalog Number FVL10120 |
Device Problems
Positioning Failure (1158); Fracture (1260); Misfire (2532)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/22/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a stent placement procedure, stent allegedly failed to deploy.There was no reported patient injury.
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Manufacturer Narrative
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The catalog number identified in the udi#: 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 common device name and the pma/510k.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.Udi#: (expiry date: 05/2024).Device pending return.
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Event Description
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It was reported that during a stent placement procedure, stent allegedly failed to deploy.It was further reported that the procedure was completed.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 returned for evaluation.The outer sheath of the returned sample showed signs of elongation and was fractured on the proximal end 30 mm from the swivel nut.The stent graft was partially deployed for a length of 9mm.Provided pictures also show a partially deployed and fractured delivery system.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 these steps were reportedly followed.Based on the provided information the investigation is closed with a confirmation for partial deployment and fracture.The reported use of the device to treat the popliteal artery aneurysm 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 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 9f and a 0.035" guidewire.Regarding indications for use it states: 'for use in the iliac and femoral arteries¿.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'.H10: (expiry date: 05/2024).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.
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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: no sample was available for evaluation.Provided pictures show a partially deployed and fractured delivery system.A process related issue could not be identified.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 these steps were reportedly followed.Based on the provided information the investigation is closed with a confirmation for partial deployment and fracture.The reported use of the device to treat the popliteal artery 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 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 9f and a 0.035" guidewire.Regarding indications for use it states: 'for use in the iliac and femoral arteries¿.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'.H10: b5, d4(expiry date: 05/2024), 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.H3 other text : device not returned.
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Event Description
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It was reported that during a stent placement procedure, stent allegedly failed to deploy.It was further reported that the procedure was completed.There was no reported patient injury.
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Search Alerts/Recalls
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