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Device Problems
Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
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Patient Problems
Perforation (2001); Thrombosis (2100)
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Event Date 01/03/2019 |
Event Type
Injury
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Event Description
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On (b)(6) 1996 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) scan of the abdomen/pelvis-infrarenal revealed there was a strut that was misaligned and found on ct to be perforating the duodenum itself.The physician performed multiple attempts at snaring the filter tip, but could not engage the tip of the filter with the snare as it appeared to be covered with intimal hyperplastic tissue.Another sheath was attempted and the physician could not advance the inner sheath over the filter so this was placed just above the filter as the outer 16- french sheath was used to entrap the filter, this was successful.It was noted during removal that the laterally oriented strut appeared to be consistent with the strut that was responsible for the caval and duodenal perforation.It easily slid back into the lumen of the vena cava and into the sheath without much difficulty.It was noted that the entire sheath and filter were removed as a unit.On (b)(6) 2019 ct scan showed fat stranding in the retroperitoneum/pericaval region likely related to recent ivc filter and strut removal perforating the duodenum.Small filling defect noted in the ivc at chest below the level of the renal veins, suggestive of a nonocclusive thrombus.
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Event Description
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On (b)(6) 1996 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) scan of the abdomen/pelvis-infrarenal revealed there was a strut that was misaligned and found on ct to be perforating the duodenum itself.The physician performed multiple attempts at snaring the filter tip, but could not engage the tip of the filter with the snare as it appeared to be covered with intimal hyperplastic tissue.Another sheath was attempted and the physician could not advance the inner sheath over the filter so this was placed just above the filter as the outer 16- french sheath was used to entrap the filter, this was successful.It was noted during removal that the laterally oriented strut appeared to be consistent with the strut that was responsible for the caval and duodenal perforation.It easily slid back into the lumen of the vena cava and into the sheath without much difficulty.It was noted that the entire sheath and filter were removed as a unit.On (b)(6) 2019 ct scan showed fat stranding in the retroperitoneum/pericaval region likely related to recent ivc filter and strut removal perforating the duodenum.Small filling defect noted in the ivc at chest below the level of the renal veins, suggestive of a nonocclusive thrombus.It was further reported that on (b)(6) 1996 the patient underwent placement of a greenfield vena cava filter.
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Search Alerts/Recalls
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