Catalog Number FVL06080 |
Device Problems
Fracture (1260); Misfire (2532); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a stent placement procedure in the right femoral artery, the stent allegedly partially deployed and resistance was met when the stent was started to release.Despite multiple attempts, still the stent allegedly failed to release.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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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.The investigation of the reported event is currently underway.The catalog number identified 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.(expiry date: 09/2022).
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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 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.Investigation summary: the sample was not returned for evaluation and image was not provided for review.Therefore, the investigation is inconclusive for the reported issue.The system was flushed, and appropriate introducer sheath was used.Additionally, it is known that the system was straightened prior to deployment.The definitive root cause could not be determined based upon 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 graft deployment'.Regarding the anatomy of the placement site the instructions for use states: 'prior to stent graft graft deployment (.), ensure that the proximal stent graft 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.H10: d4 (expiry date: 09/2022), g3 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 in the right femoral artery, the stent allegedly partially deployed and resistance was met when the stent was started to release.Despite multiple attempts, still the stent allegedly failed to release.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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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.Investigation summary: the physical sample was returned for evaluation.Based on the evaluation of the sample, the fracture of the outer sheath was identified as the main issue to the reported event, which led to the partial deployment of the stent graft.Based on the investigation of the provided information, the investigation is closed as confirmed for fracture of the outer sheath and subsequent partial deployment.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 (ifu) 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 graft deployment'.Regarding the anatomy of the placement site the instructions for use states: 'prior to stent graft graft deployment, ensure that the proximal stent graft 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 ifu 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.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: d4 (expiry date: 09/2022), g3, h2, h6 (device).H11: g1, 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 : see h10.
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Event Description
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It was reported that during a stent placement procedure in the right femoral artery, the stent allegedly partially deployed and resistance was met when the stent was started to release.Despite multiple attempts, still the stent allegedly failed to release.The procedure was completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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