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COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Catalog Number IGTCFS-65-FEM |
| Device Problems
Obstruction of Flow (2423); Structural Problem (2506); Detachment of Device or Device Component (2907); Unintended Movement (3026)
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| Patient Problems
Internal Organ Perforation (1987); Pain (1994); Thrombosis (2100); Perforation of Vessels (2135); Distress (2329); Depression (2361)
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Event Type
Injury
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Manufacturer Narrative
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Initial reporter occupation: non-healthcare professional.Investigation: the reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: fracture, vena cava (vc) perforation, migration, tilt, and disfiguring injuries (pain, distress, limited activity).Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.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 or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; 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: filter migration, trauma to adjacent structures.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 disfiguring injuries (pain, distress, limited activity) are directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of (b)(4) devices were manufactured in the reported lot.To date, one other complaint has been reported against the lot, pr240766.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to current controls.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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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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The following information is alleged: the patient received a gunther tulip on (b)(6) 2006.Approximately 12 years and 6 months after receiving the filter implant, the patient underwent a computed tomography (ct) scan of the abdomen which revealed that a strut of the filter had fractured and migrated into the left renal vein of the left kidney.The ct scan also revealed that the filter had tilted approximately 56 degrees off the horizontal and there was perforation of the inferior vena cava (ivc) wall.It was further alleged that the patient experienced "significant disfiguring injuries, including significant pain and distress restricting [the patient's] ability to engage in activities of daily living." hospital and medical records have been requested, but not yet provided.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a2, a4, b5, b6, b7, h6 (patient codes).Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: organ perf, deep vein thrombus, and depression the reported allegations have been further investigated based on the information provided to date.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.Unknown if the reported depression is directly related to the filter and unable to identify a corresponding failure mode at this point in time.The additional information regarding organ perforation does not change the previous investigation results for vena cava perforation.A total of (b)(4) devices were manufactured in the reported lot.To date, one other complaint has been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to current controls.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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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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Patient allegedly received an implant via the right common femoral vein due to post pulmonary embolism (pe).Patient is alleging migration, tilt, vena cava and organ perforation, fracture and deep vein thrombosis (dvt).Patient further alleges experiencing physical limitations and depression.Per the 08mar2019 computed tomography (ct) abdomen without contrast: "there is evidence of a piece linear foreign body involving the lower pole left kidney.Extends from the lower pole right gland 2 collecting system region of the renal pelvis.I cannot exclude that this is migration of a ivc strut into the region of the left kidney involving the inferior branch left renal vein into the left renal parenchyma.There is no penetration asked to the renal cortex.Differential would include that this may be a broken stent"."and ivc filter appears tilted.Approximately 56 degrees off the horizontal.There are mammo 3 definitive struts identified associated with the parent ivg filter in the vena cava.There appears to be perforation of the ivc involving the medial strut and this is located approximately 5 mm out of the ivc wall the other struts are more equivocal for possible perforation.Seen to the intimately associated with the wall of the ivc.The anterior strut is seen intimately associated with the anterior wall.The tip is occurring also intimately associated with the adjacent duodenal sweep.Therefore the anterior strut is equivocal here for.There is no involvement of the adrenal glands.No involvement pancreas.No involvement of the kidney.No involvement of the musculature.The right lateral strut tip is along the ivc and again equivocal but no definitive perforation.The tip of the ivc filter is at the level of the superior end plate at l2 and the inferior strut ends at the level of mid body l3.Importantly the tip is intimately associated with the ivc wall on the right.The tip is felt to lie just above or at the entry of the right renal vein however does not extend into the right renal vein.There is no evidence of vena caval significant stenosis here.".
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