Catalog Number FVL10080 |
Device Problems
Positioning Failure (1158); Misfire (2532)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/14/2017 |
Event Type
malfunction
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Manufacturer Narrative
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No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.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 vascular stent graft products that are cleared in the us.The 510 k number and pro code for the fluency plus vascular stent graft products are identified.Accordingly, this event has been determined to be mdr reportable.The information provided by bard 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 bard.
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Event Description
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It was reported that during a stent graft deployment procedure in the internal iliac, the vascular stent graft allegedly partially deployed and became stuck in the vessel.Current patient status is unknown.
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Manufacturer Narrative
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Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Visual inspection: the sample was not returned; therefore, a visual inspection could not be performed.Functional/performance evaluation: the sample was not returned; therefore, functional/performance evaluation could not be performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was not returned; therefore, the alleged failure could not be verified.The investigation result was inconclusive.Based on the information available, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device the ifu 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 ifu 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.".
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Event Description
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It was reported that during a stent graft deployment procedure in the internal iliac, the vascular stent graft allegedly partially deployed and became stuck in the vessel.Current patient status is unknown; however, there was no reported patient injury.
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Manufacturer Narrative
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Manufacturing review: the lot history records have been 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.No manufacturing anomalies or changes which may have caused or contributed to the reported event have been identified.No additional complaints have been reported for this lot number previously.Investigation summary: on the basis of the returned stent graft delivery system, the alleged deployment failure could be confirmed.The stent graft was found partially released and the outer sheath was found to be elongated, which indicated that increased friction affected the delivery system during attempt of stent graft deployment.As a result of the investigation performed the complaint was confirmed.Based on the available information and the evaluation of the returned sample, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device the ifu 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 ifu 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.".
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Event Description
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It was reported that during a stent graft deployment procedure in the internal iliac, the vascular stent graft allegedly partially deployed and became stuck in the vessel.Current patient status is unknown; however, there was no reported patient injury.
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Search Alerts/Recalls
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