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| Catalog Number UNKNOWN |
| Device Problems
Inadequate Filtration Process (2308); Structural Problem (2506); Detachment of Device or Device Component (2907); Insufficient Information (3190)
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| Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Internal Organ Perforation (1987); Perforation of Vessels (2135); 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.It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.
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Event Description
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Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2008.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".
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Manufacturer Narrative
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Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.New pe 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: pulmonary embolism.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.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.Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up.The risks/benefits of filter retrieval should be considered for each patient during follow-up.Once protection from pe is no longer necessary, filter retrieval should be considered.Filter retrieval should be attempted when feasible and clinically indicated.Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e.G., a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications).For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.The filter is designed to be retrieved with the günther tulip vena cava filter retrieval set.It may also be retrieved with the cloversnare® vascular retriever.Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques.The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position.The safety or effectiveness of these alternative retrieval techniques has not been established.Specific for ¿embedded¿ a filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.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 fear, pain, numbness, impaired cognitive function, sleep disturbance, physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot# are unknown.The following allegations have been investigated: pulmonary embolism, fracture, vc perforation, embedment, occlusion, thrombosis/blood clots, stenosis, inability to retrieve, tilt, fear, pain, numbness, impaired cognitive function, sleep disturbance, physical limitations.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) 2020 via the right femoral vein due to bariatric procedure.Patient is alleging fracture, inability to retrieve.Patient further alleges fear, chest pain, back pain, numbness in the extremities, impaired cognitive function, sleep disturbance, blood clots, deep vein thrombosis, pulmonary embolism, physical limitations.Retrieval report: "the filter is canted leftward with the hook apparently embedded in the wall of the cava." ".Tried several different oblique projections and different shapes on the snare but i was not able to snare the hook." "i then removed the balloon and then again attempted to snare the hook but the hook still seemed embedded into and this was unsuccessful.At this point, i stopped the procedure." retrieval report (attempted): "unfortunately, the tip of the filter was tipped in contact with the wall of the inferior vena cava and appeared to be quite adherent, most likely incorporated with tissue growing from the wall of the vena cava itself.Despite of numerous attempts and techniques, the snare would not capture the tip of the filter." "the balloon was able to be positioned between the filter and the wall and then was inflated.This was successful in bringing the tip of the filter more towards the midline.It was not clear however whether the wall of the inferior vena cava was moving with the embedded tip or whether the tip itself was free.Utilizing the balloon from below and the snare and snare catheter from above a length period of time, range of up to 20 minutes was used to try to capture the filter without success." report from computerized tomography (ct): "moderate abnormal filling defects within segmental and subsegmental pulmonary artery branches to the right middle and right lower lobes consistent with moderate pulmonary embolism." "there is an ivc filter noted with the struts penetrating the ivc wall." report from computerized tomography (ct)2: "moderate abnormal filling defects within segmental and subsegmental pulmonary artery branches to the right middle and right lower lobes consistent with moderate pulmonary embolism." "maximum intensity projections confirm filling defects within segmental and subsegmental pulmonary artery branches to the right middle lobe and right upper lobe consistent with pulmonary embolism." report from ct: "there is no made of an ivc filter.Several of the struts penetrate the wall of the ivc, one of which extends medially to posterior to the aorta but does not appear to reach the wall of the aorta." report from ct2: "ivc is present, it is occluded with thrombus.The thrombus propagates superior to the filter to the level of the renal vein." report from ct: "ivc filter in place.There appears be infrarenal ivc clot extending into the right common femoral vein." retrieval report (unsuccessful): "the left common iliac vein is still functionally obstructed by thrombus." "the right femoral vein is occluded by thrombus." "there is thrombus within the inferior vena cava beneath the filter but the ivc is partially recanalized." "the inferior vena cava filter looks to be damaged presumably from previous unsuccessful retrieval efforts." "the inferior vena cava filter looks to be damaged presumably from previous unsuccessful retrieval efforts.This looks to be a conical filter with longer primary legs and secondary inner skirt., i think this is a celect filter, but one of the longer legs is severely angulated and may be chronically disrupted.(interestingly, imaging over the patients left lower quadrant under fluoro shows what appears to be a broken filter leg in an ectopic position as well.This requires additional clinical correlation.) there is a caval stenosis at the conical aspect of the filter, and there is propagation of thrombus above the level of the filter." report from venogram: "sub occlusive acute and chronic thrombus in right popliteal and femoral vein with some flow.No flow in proximal femoral, common femoral, external iliac, and common iliac vein.No flow in infrarenal ivc or through ivc filter." report from venogram: "continued thrombosis of ivc from just below the renal veins to the left common femoral vein.Copious residual thrombus noted in right femoral and popliteal vein.Patency of left popliteal, femoral, common femoral, and external iliac veins.Thrombosis of left common iliac vein.".
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Event Description
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23apr2020: per ct report, "ivc filter with: 13 mm vertebral, and 3 mm mesenteric perforation.Tilting with the apex against the ivc wall.There is a stent representing ivc stenosis.No fracture, or migration.".
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Manufacturer Narrative
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Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: organ perforation.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 and embedment.Catalog and lot number are unknown, however, the alleged celect 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.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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Search Alerts/Recalls
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