Description of event according to initial reporter: physician stated she was unable to deploy the celect platinum jugular ivc filter, after correctly activating the red unlock button and then pressing the deployment button, because it would not release from the deployment mechanism.She describes moving the whole system in an attempt to get the celect to deploy.It did eventually release but now the filter has two of its secondary struts in an abnormal position.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Manufacturer ref#: (b)(4).Summary of investigational findings: the physician was unable to deploy the filter after pressing the release mechanism.The physician tried to move the device in attempt to deploy the filter.The filter did eventually release but two secondary legs was in an abnormal position.Two fluoroscopic images from time of ivc filter placement were provided for imaging review.Per imaging reviewer´s findings: two fluoroscopic images from time of the ivc filter placement demonstrate a celect platinum ivc filter to the right of the spine with hook terminating at the superior endplate of the l2 vertebral body.On the first image, the distance between the primary filter feet measuring approximately 20 mm and there is 1 degree of rightward tilting relative to the posterior spinous processes.The maximal distance between the secondary filter feet measures approximately 25.5 mm.Two of the secondary arms are displaced slightly more lateral, towards the right, when compared with the remaining primary and secondary arms/legs in this region.The deployment mechanism is still within the sheath and terminates approximately 2 cm cranial to the hook of the ivc filter.The second image demonstrates interval removal of the deployment mechanism of the ivc filter, but the introducer remains in the ivc.The filter angulation and distance between the primary filter feet remain unchanged.The distance between the secondary filter feet now measures 33 mm and the 2 lateral most secondary filter arms are now even more displaced towards the patient's right.The hook of the ivc filter continues to terminate at the superior endplate of the l2 vertebral body.Per imaging reviewer impression's: per the complaint report, the deploying physician identified the appropriate location to deploy the celect platinum ivc filter, activated deployment mechanism by unlocking the safety and pressing the deployment button.However, the filter would not release from the deployment mechanism.The complaint report does not specify if excessive back tension was applied to the filter during deployment, as it is specified in the ifu this can cause issues with detachment.Furthermore, from the submitted images, it is uncertain if the deployment mechanism did not detach from the ivc filter, or rather would not exit the patient's body.This image submitted for review demonstrates the deployment mechanism still in the ivc but shows a gap of approximately 2 cm between the hook of the ivc filter and the tip of the deployment mechanism.If the mechanism would still not come out at this point, the grasping hook has inadvertently engaged with the wall of the ivc, and when the physician was trying to retract the deployment mechanism, this was in turn pulling on the ivc and the adjacent tissues causing the filter to move with the ivc.On this initial image, the lateral two rightward directed secondary filter legs appear to extend more laterally than the primary filter legs and likely already at this point extend barely into the right renal vein ostium or a collateral/lumbar vein in this region.The venogram was not submitted to confirm which vessel these legs extended into.With manipulation of the deployment mechanism, attempting to remove it, this likely accentuated the extension of the secondary filter legs into this vessel as is better appreciated on the final radiograph.If the patient was severely dehydrated and/or ivc was slit-like in configuration, while detaching the filter hook the from the grasping hook, the grasping hook may inadvertently engage with the wall of the ivc resulting in the above-described scenario.In addition, if excessive back tension is applied during deployment, the grasping hook may not disengage from the ivc filter appropriately.With the secondary legs in the current configuration, this may increase the likelihood of fracture, tilt or perforation and repositioning of the filter should be considered if the ivc filter is still clinically indicated.Coaxial introducer system and the jugular introducer was returned for device evaluation.The red safety button was released on the jugular introducer and the sheath was kinked.There was no nonconformances observed at the grasping hook and it was possible to attach and detach a test filter from the jugular introducer.No nonconformances were observed on the introducer sheath.An exact cause for the reported failure cannot be determined based on the device evaluation, however use of excessive back tension during release may prevent the filter from being released.It was assessed that because any discovered non-conformances were dispositioned before qc release, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.According to the instruction for use excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.There are adequate controls in place to ensure the device was manufactured to specifications.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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