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Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.Investigation is reopened due to additional information provided.The following allegations have been investigated: migration, tilt, fracture, vena cava perforation, numbness, disability, shortness of breath, and unable to retrieve.The reported allegations have been further 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.Vena cava wall penetration/perforation has been reported and 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.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.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 numbness, disability, sob are directly related to the filter and unable to identify a corresponding failure mode at this point in time.No relevant notes on wo (work order) for neither device lot, nor filter lot numbers.No other complaints on lot.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.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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Additional information received identified that the patient allegedly received a cook celect femoral vena cava filter implant on (b)(6) 2008 via the right common femoral vein due to trauma resulting from an accident.The patient is alleging migration, tilt, and fracture.The patient further alleges two of the filter's fractured prongs were visualized outside of the normal confines of the vascular territory and the migrated filter was extracted but the prongs are unable to be removed.The prongs remain within the body which at any point can migrate, perforate organs and put him at risk of death.Additionally, the patient alleges numbness radiating from his back to legs, being permanently disabled, difficulty climbing steps due to shortness of breath and leg issues, and the inability to play sports, volunteer coach or do chores around the house.Per the (b)(6) 2008, radiology report: " inferior vena cava filter is also noted with upper tip superimposing with l1 vertebral body".Per the (b)(6) 2016, radiology report: " findings: inferior vena cava filter noted with a fractured prong noted laterally exhibiting slight distal migration.Incomplete evaluation of a linear metallic density overlying the right inguinal region could reflect a 2nd fracture prongs.Impression: 2.Inferior vena cava filter noted with a fractured prong demonstrating slight distal migration.Incomplete evaluation of a 2nd linear metallic density overlying the right inguinal region could also reflect a fractured prominent with distal migration".Per the (b)(6) 2017, x-ray-abdomen anteroposterior and oblique: "findings: inferior vena cava filter is seen at the l2-3 level.Fractured pieces of the filter are seen in outside the expected confines of the vascular territory to the right of the spine at l3 and in the right inguinal region.Impression: inferior vena cava filter with 2 fractured pieces outside the expected confines of the vascular territory as described above".Per the (b)(6) 2018, x-ray- abdomen: "findings: inferior vena cava filter at the l2-3 level.Fracture pieces of the filter again appreciated to the right of the spine at l3 and in the right inguinal region.Impression: fractured inferior vena cava filter is re-demonstrated with 2 fractured pieces overlying the right abdomen at the l3 level and over the right inguinal region".Per the (b)(6) 2019, retrieval report (successful):" findings: filter removed through the sheath successfully.2 tines remained.Ivc cavogram repeated with no caval defects to suggest rupture or residual thrombus.No connection with tine in the abdomen.Right common femoral venogram with no vein seen near the tine in the right groin".
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