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As noted in the literature publication by stavropoulos et al retrieval of tip-embedded inferior vena cava filters by using the endobronchial forceps technique: experience at a single institution, radiology (2015) 1-8; a 49-year-old female patient had a tip embedded optease filter.The filter was severely distorted filter when presented to the hospital.The indwelling time was < 338 days.Part of the filter was extracaval at time of removal.The distortion required removal and replacement of filter.At time of removal, patient had recurrent pe in spite of filter being in place, which was severely distorted.There was no fracture.The indication for filter insertion was dvt and pe.Photo was provided upon investigation.At the time of removal, there were no acute bends or tortuosity (including access site).A quality assurance database of prospectively captured ivc filter retrievals to identify all patients who had an attempted removal of a tip-embedded filter from january 2005 to april 2014.All these patients were included in this study.During this period, 114 patients presented to the interventional radiology clinic for attempted removal of a tip-embedded ivc filter.This group consisted of 77 women and 37 men.Before the clinic visit, patients underwent computed tomographic (ct) venography of the abdomen and pelvis to evaluate for filter tilt, fracture, filter strut penetration, and ivc thrombus.Filter strut penetration was evaluated by using the grading system of oh and colleagues (14): grade 0, no penetration, grade 1 penetration, extraluminal appearance on ct scan; and grade 3 penetration, involvement of the strut with an adjacent organ.The deep venous system of the legs was evaluated with doppler ultrasonography or cto venography at the same time as abdominopelvic ct venography.During this visit, current need for the ivc filter was determined.Indications for filter retrieval included the following: the risk for pulmonary embolism had passed or the patient could safely undergo anticoagulation.If the filter appeared likely to be embedded according to ct or an imaging examination performed outside the hospital during a period retrieval attempt, an extensive informed consent process was undertaken in which the potential need for the endobronchial forceps technique was explicitly discussed with the patient.Because the rigid endobronchial forceps is a class 1 device, this does not constitute off label use; there are no instructions for use.Final determination of an embedded filter tip was not made until rotational venography was performed at the start of the retrieval procedure.All the procedures were performed with the patient receiving moderate sedation with fentanyl and midazolam, titrated to effect.Magnification spot radiographs of the filter were obtained prior to venous access to further assess for fracture before manipulation of the filter.After us-guided access of the right internal jugular vein was obtained, rotational venography was performed by using a flush catheter with half strength contrast material (isovue 300) with an injection rate of 15 ml/ sec for 6 seconds and a 2-second x-ray delay.When an embedded filter was diagnosed at venography, the endobronchial forceps technique was used.A 12-f, 45-cm sheath (cook medical) was loaded coaxially into a 14-f, 30-cm sheath (cook medical) and advanced into the ivc via the right internal jugular vein.The sheaths were positioned just above the tip of the ivc filter.Rigid bronchoscopy forceps were then placed through the 12-f sheath to the top of the filter.The forceps were gently bent near the grasping end on the basis of the tip location identified at ct and rotational venography, such that the tip of the forceps could be positioned at the superior aspect of the filter hook.Further, the bend was performed in such a way as to allow the open jaws of the forceps to approach the filter tip.The c-arm was then angled in a position that optimally showed the embedded tip according to the findings on the rotational venogram.The forceps were then used to dissect the tip of the ivc filter free from the wall of the ivc by using gentle movements to remove tissue around the filter tip.Once the forceps were thought to contact the metal of the hook or tip of the ivc filter, the tip was grasped with the forceps.This often took several attempts before the tip was firmly in the jaws of the forceps.The forceps were then turned 90° to ensure that the tip was not protruding from the side, which would preclude withdrawal into the sheath.Depending on filter design, the captured tip was oversheathed (günther tulip [cook medical], optease [cordis, (b)(4)], celect [cook medical], and option [argon, (b)(4)]) or pulled into the sheath (recovery [bard pv, (b)(4)], g2 [bard pv], g2x [bard pv], eclipse [bard pv], and aln [aln international, (b)(4)]) per the manufacturer¿s instructions.Combinations of these two maneuvers were often necessary.If the filter could not be oversheathed, the most common reason was grasping of the filter too far below the superior tip, with the endobronchial forceps not allowing the hook or tip of the filter to go into the sheath.On retrieval of the filter, postretrieval venography was then performed in the same projection as the dissection.Attempts were then made to remove fractured filter fragments, if any, by using the forceps or a snare during the same procedure.The patient was then observed in the interventional radiology recovery area for 2¿4 hours and was subsequently discharged.Follow- up was performed in the office (or by telephone for patients living out of the area) at 1 month.The endobronchial forceps technique was attempted in 113 of 114 patients.109 patients had their filters successfully retrieved.All retrieval attempts but one occurred via the right internal jugular vein; the exception was a single optease filter that was removed by using a right common femoral venous approach.
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This is the initial and final report for this complaint.This article was found during a recent literature search of this device.The citation is as follows: stavropoulos, s.W (2015,january 12).Retrieval of tip-embedded inferior vena cava filters by using the endobronchial forceps technique: experience at a single institution, radiology,000, 1-8.Complaint conclusion: as noted in a literature article, an optease retrievable vena cava filter could not be retrieved by standard technique over eleven months after implantation.The filter was removed with the use of endobronchial biopsy forceps with no reported patient injury.One of the events involved a 49 year old female patient who presented with pulmonary emboli and deep vein thrombosis who had undergone implantation of an optease filter in her inferior vena cava (ivc).More than eleven months after the implantation, the patient had recurrent pulmonary emboli despite the filter.The optease filter was noted to severely distorted (without fracture) and part of the filter was extra-caval.This distortion necessitated filter removal and replacement.During the successful retrieval, the site reported that the patient¿s vasculature had no acute bends or tortuosity.Access was obtained via the right common femoral vein.Endobronchial biopsy forceps were then used to carefully dissect the tip of the ivc filter to free it from the wall of the ivc.Once free, the ivc filter was over-sheathed and removed with no reported patient injury.The product was not returned for analysis.A device history record (dhr) review was performed and showed that this lot of products met specification prior to release.According to the product instructions for use (ifu), the optease retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism via percutaneous placement in the vena cava.Available clinical data suggest that the optease filter can be safety retrieved between five to fourteen days after implantation.Lastly, an inability to retrieve the filter is a listed as a potential complication with the use of this device.Based on the information available for review, there are procedural factors (retrieval attempt over two months after implant) that may have contributed to this event.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore no corrective and preventive actions will be taken at this time.
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