COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Model Number G33016 |
Device Problems
Obstruction of Flow (2423); Appropriate Term/Code Not Available (3191)
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Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
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Event Type
Injury
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Manufacturer Narrative
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The previous medwatch report was submitted by william cook (b)(4) under manufacturer report reference# 3002808486-2019-01968.Additional information provided determined that this device was manufactured by cook inc.With the submission of this initial medwatch report, cook inc.Informs that all future submissions regarding this complaint will be handled under the manufacturer report reference #.Reporter occupation: non-healthcare professional.(b)(4).Investigation: the following allegations have been investigated: vena cava perforation, tilt, embedment, pain/back pain, limited mobility.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported pain/back pain, limited mobility are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.No relevant notes on work order.The product is manufactured and inspected according to specifications.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.
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Event Description
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Patient allegedly received an implant on (b)(6) 2012 via right femoral vein due to deep vein thrombosis (dvt) and/or pulmonary embolism (pe).Patient is alleging tilt and vena cava perforation.The patient further alleges back pain, difficult to walk a lot/work on automobile/carry groceries/various household chores, and embedment.15jun2019, per a report from computed tomography (ct); ¿findings: inferior vena cava: there is a metallic vena cava filter device present with the apex of the device at l2 extending to l3-l4 disc space level.The apex of the device is along the medial aspect of the inferior vena cava.Measurement of result is difficult with the tortuosity and scoliosis.Approximately 11 degrees with the apex to the left coronal plane.No significant ap tilting.The metallic limbs appear intact.Posterior limb extends 2 mm posterior to the inferior vena cava adjacent to anterior osteophytes l3-l4 disc space.It appears to be eroding or embedded in an anterior osteophyte best visualized axial image 253 series 6.Posterior right limb 2 mm peripheral to the inferior vena cava.The inferior vena cava measures 19 mm above, 15 mm at and 17 mm diameter below the device.The left common iliac vein is somewhat narrowed between the distal aorta and a large osteophyte arising from l4-l5 vertebral body with diameter of approximately 6 mm best visualized axial image 322 series 6.Conclusion: inferior vena cava filter as above.Position and tilt as discussed above.Limbs peripheral to the vena cava as above.One of the limbs appears eroded or embedded in the anterior osteophyte l3-l4.¿.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation.The following allegations have been investigated: organ perforation, occlusive clot.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The additional information regarding organ perforation does not change the previous investigation results for vena cava perforation.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.20 devices in lot.No relevant notes on work order.The product is manufactured and inspected according to specifications.No evidence to suggest that this device was not manufactured according to specifications, and nothing indicates that the filter did not perform as intended, e.G., intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.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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Event Description
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06aug2022, per a report from medical opinion; ¿the patient¿s ivc filter is a cook gunther-tulip retrievable ivc filter positioned in the patient¿s infrarenal ivc at the l2-3 level.The patient¿s ivc measures 22 mm in maximum diameter at the level of the filter.The filter is significantly tilted (18 degrees medially), such that the filter apex and hook are in direct contact with, and likely embedded in, the caval wall just below the l renal vein.Two (2) of the filter¿s four (4) legs (primary struts) perforate the wall of the ivc by a distance of 3 mm or greater.The perforating posterior strut penetrates into and adversely interacts with the anterior portion of the underlying l3-4 disc and superior portion of the l4 vertebral body.No strut fractures or missing components are identified.No pericaval hemorrhage.The contrast enhanced abd/pelvis ct, performed on 11-18-2013, demonstrates partially occlusive clot within the patient¿s ivc below (caudal to) the filter.Unfortunately, iv bolus timing on the patient¿s 6-15-2019 ct study was not optimized for venous vascular enhancement.I cannot definitively evaluate for caval thrombosis, clot within the filter, caval wall thickening or caval stenosis on the 2019 study.¿.
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