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Model Number 466P306X |
Device Problem
Difficult to Remove (1528)
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Patient Problems
Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
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Event Date 05/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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As reported in the literature article by elboraey, m., toskich, b.B., lewis, a.R., ritchie, c.A., frey, g.T., & devcic, z.(2021).Iliocaval reconstruction of chronically thrombosed cylindrical inferior vena cava filters with balloon expandable covered stent-grafts.Journal of vascular surgery cases and innovative techniques, 7(3), 454¿457.Https://doi.Org/10.1016/j.Jvscit.2021.05.006, ten years after implantation, computed tomography (ct) demonstrated a trapease ivc filter was thrombosed and calcified with partial occlusion of the left common and external iliac veins.The patient required recanalization for symptomatic iliocaval occlusion.Pharmacomechanical thrombectomy was followed by attempted ivc filter retrieval using a non cordis excimer laser and non cordis endobronchial forceps, but was unsuccessful due to the large volume of calcified thrombus, which prevented laser sheath advancement.Ivc filter exclusion and iliocaval reconstruction were performed with parallel bilateral overlapping 12mmx80mm and 14mmx80mm smart ses stents dilated using venoplasty.The smart stents at the level of the ivc filter were narrowed, with repeated high-pressure balloon rupture.They were reinforced with parallel non cordis balloon expandable stent-graft.The patient was hospitalized for 2 days.Nine month follow up demonstrated patent bilateral cfvs, femoral veins (fvs),and popliteal veins (pvs).The device was not returned for analysis.A product history record (phr) review could not be conducted as a lot number was not provided.The reported ¿filter-retrieval difficulty, thrombosis in device and iliac vein occlusion¿ could not be confirmed as the device was not returned.The exact cause of the reported events could not be conclusively determined.Procedural factors, such as operator technique, or vessel characteristics, although unknown, may have contributed to the reported event.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿the trapease vena cava filter is designed for percutaneous delivery of a permanent vena cava filter to the ivc.Possible procedure complications include, but are not limited to, occlusion of small vessel and thrombus formation.¿ thrombosis in device and/or occlusion within the ivc does not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.Without procedural films to review, the reported retrieval difficulty could not be confirmed.Without a lot number to conduct a phr review, or any other product information, it is not possible to make a clinical decision whether the reported event could be related to the design or manufacturing process; therefore, no corrective and preventive actions will be taken at this time.
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Event Description
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As reported in the literature article by elboraey, m., toskich, b.B., lewis, a.R., ritchie, c.A., frey, g.T., & devcic, z.(2021).Iliocaval reconstruction of chronically thrombosed cylindrical inferior vena cava filters with balloon expandable covered stent-grafts.Journal of vascular surgery cases and innovative techniques, 7(3), 454¿457.Https://doi.Org/10.1016/j.Jvscit.2021.05.006, ten years after implantation, computed tomography (ct) demonstrated a trapease ivc filter was thrombosed and calcified with partial occlusion of the left common and external iliac veins.The patient required recanalization for symptomatic iliocaval occlusion.Pharmacomechanical thrombectomy was followed by attempted ivc filter retrieval using a non cordis excimer laser and non cordis endobronchial forceps, but was unsuccessful due to the large volume of calcified thrombus, which prevented laser sheath advancement.Ivc filter exclusion and iliocaval reconstruction were performed with parallel bilateral overlapping 12mmx80mm and 14mmx80mm smart ses stents dilated using venoplasty.The smart stents at the level of the ivc filter were narrowed, with repeated high-pressure balloon rupture.They were reinforced with parallel non cordis balloon expandable stent-graft.The patient was hospitalized for 2 days.Nine month follow up demonstrated patent bilateral cfvs, femoral veins (fvs),and popliteal veins (pvs).The device will not be returned for evaluation.
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Search Alerts/Recalls
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