|
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).G1) name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.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.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.
|
|
Additional information received identified the patient allegedly received a cook celect femoral and jugular vena cava filter implant on (b)(6) 2008 via the right common femoral vein due to pulmonary embolism and a pelvic mass.The patient is alleging migration, vena cava perforation and fracture.The patient further alleges, "stomach pains, chest pains, shortness of breath, pain when bending forward, pain when turning and pain when sleeping.It is hard for me to do any kind of lifting and i can only walk for short distances".It was also reported that per the (b)(6) 2009, retrieval report (attempted): "procedures: unsuccessful filter retrieval.There is evidence for a small filling defect within the central filter and extends cephalad around the hook of the filter.This is consistent with a thrombus.A sheath is advanced down to the filter.The snare does not engage the top of the filter; this is felt to be secondary to the thrombus on the filter.The procedure is aborted and the filter will be left in place secondary to the thrombus present.Impression: initial attempt to remove inferior vena cava filter.The venogram demonstrates a small amount of clot centrally within the filter extending to the tip engulfing the hook of the filter.The filter is left in place".Additionally, per the (b)(6) 2016, retrieval report (successful): "procedure: an introducer sheath was then placed over the guidewire into the inferior vena cava and an inferior vena cavagram was performed demonstrating no thrombus in the filter or the inferior vena cava.Noted on the scout image is a broken tine inferior to the filter on the left.Through the sheath a 25 mm snare was utilized multiple times in an attempt to capture the filter hook unsuccessfully.Next through the 12 french sheath a glidewire and pigtail catheter were advanced through the inferior vena cava filter and the glidewire tip directed cranially which was captured with the snare and withdrawn through the sheath.The ligament glidewire enabled straightening of the filter which was then sheathed, and the filter vas retracted into the sheath.The filter was then delivered through the sheath.A completion inferior venacavogram demonstrated removal of the filter without evidence of complication.The sheath was removed and hemostasis obtained with manual compression.Findings: initial fluoroscopic imaging demonstrated a previously placed inferior vena cava filter.Completion inferior venacavogram demonstrated removal of the filter without complication.The previously fractured tine of the filter remained in place.Impression: retrieval of inferior vena cava [filter] with ultrasound and fluoroscopy as detailed above.Inferior vena cavogram showing no thrombus within the inferior vena cava and no complication post retrieval".
|
|
Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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 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.Unknown if the reported pain, shortness of breath, disability are directly related to the filter and unable to identify a corresponding failure mode at this point in time.The following allegations have been investigated: migration, vc perforation, fracture, pain, shortness of breath, disability, unable to remove.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 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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.
|
