Catalog Number FVL10120 |
Device Problems
Break (1069); 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 11/26/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a stent placement procedure, the device allegedly failed to deploy.It was further reported that the device shaft broke.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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The catalog number identified 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 records is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.Medical device expiration date: 02/2024, device pending return.
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Event Description
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It was reported that during a stent placement procedure, the device allegedly failed to deploy.It was further reported that the device shaft broke.The procedure was completed using another device.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 physical sample was returned for evaluation.The outer sheath of the returned sample was fractured on the proximal end 40 mm from the swivel nut.The stent graft was partially deployed for a length of 15mm.Based on the provided information the investigation is closed with a confirmation for partial deployment and fracture.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 9f and a 0.035" guidewire.H10: (expiration date: 02/2024).H11: section a through f ¿ the information provide 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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