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WILLIAM COOK EUROPE COOK CELECT FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Catalog Number IGTCFS-65-FEM-CELECT-PERM |
| Device Problems
Obstruction of Flow (2423); Detachment of Device or Device Component (2907); Unintended Movement (3026)
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| Patient Problems
Occlusion (1984); Thrombosis (2100); Stenosis (2263); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.Summary of investigational findings: the reported allegations have been investigated based on the information provided to date.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.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.Cook medical will continue to monitor for similar events.
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Event Description
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Description of event according to initial reporter: it is alleged that ¿[pt] had a cook celect filter implanted on (b)(6) 2008.It is alleged that the celect filter fractured requiring removal.¿ patient outcome: it is alleged that ¿[pt] suffered permanent and continuous injuries, pain and suffering, disability and impairment.[pt] has suffered emotional trauma, harm and injuries that will continue into the future.[pt] has lost his ability to live a normal life, and will continue to be so diminished into the future.".
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Manufacturer Narrative
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Additional information: investigation the following allegations have been investigated: occlusion, dvt/thrombosis, stenosis, migration scarring, ivc enlargement, collapse of filter, ivc stent, crushed filter, pain, physical limitations, hospitalization.Investigation is reopened due to additional information provided.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.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.Unknown if the reported ivc enlargement, collapse of filter, ivc stent, crushed filter, pain, physical limitations, hospitalization are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Twenty devices were manufactured in the lot.No relevant notes on the work order for the device.No other complaints on lot.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 become 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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Patient allegedly received an implant on (b)(6)2008 via the right femoral vein due to car accident and risk of blood clots; followed by a percutaneous attempted filter retrieval (b)(6)2020 with subsequent crushing of the filter with a stent.Patient is alleging migration, fracture, collapse of filter, deep vein thrombosis(dvt).Patient further alleges required ivc stent, crushed filter, pain, physical limitations, hospitalization, restricted activities, difficulty walking.Report from computerized tomography (ct): "ivc filter is in place.1 of the filter struts appears to be fractured and lies within the filter cone.There is abnormal enlargement of the lvc below to the filter as well as abnormal enlargement of the iliac and proximal femoral veins with surrounding inflammatory fat standing.Findings are suggestive of acute thrombosis of the iliocaval system and proximal femoral veins.Dvt ultrasound of the lower extremities is recommended".Report from venogram/mechanical thrombectomy: "there was still a moderate amount of clot at the most proximal aspect of the femoral vein extending into the right common femoral vein, the right external iliac vein and right common iliac veins were free of clot.There was adequate flow into the inferior vena cava on the level of the confluence coming from the left common iliac vein.There was evidence of what appears to be chronic clot extending into the left common iliac vein.There was still narrowing of the left external iliac vein.There was collateralization in the pelvic vessels proximal to the area of stenosis and there was adequate flow in the left common femoral vein, left femoral vein and left popliteal vein.This was collateralization with intravascular ultrasound of these vessels.Following the percutaneous mechanical thrombectomy with inari in an up and over technique, the chronic clot was removed.There was now adequate flow through the femoral, popliteal, and iliofemoral venous segment into the infrarenal ivc flowing through the stent, and into the suprarenal ivc.There was a small amount of narrowing at the level of the ivc filter in the ivc"."there was still the presence of a strut that was an embolized and trapped at the canopy of the ivc filter, but there was adequate flow past the filter into the suprarenal inferior vena cava".On (b)(6)2020, venogram/venous balloon and stenting: "importantly the ivc filter was noted to be heavily scarred/obstructed with minimal lumen.The right ivus measurements were as follows: r cfv z2 138.3 mm2, 121.8 mm2, rov 72.8 mm2, distal 58.5 mm2.Based on the venogram and intravascular ultrasound, the decision was made to proceed with venous balloon and stenting with ivc crushing.Ivus was used to identify the proximal landing zone (lilac confluence bilaterally and renal veins) as well as the distal stent landing zone, which was zone 2 bilaterally.The thus, the distal ivc,/filter was dilated with a 24mm balloon.The bilateral common iliac veins, external iliac veins, and common femoral veins were fully balloon dilated with 18x 60mm atlas balloons.Right ij access was achieved and wire followed by sheath access of the infrarenal ivc.A wallstent was placed in the infrarenal ivc crushing the filter behind it." "repeat venogram demonstrated resolution of stenoses".
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