Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2016".Additional information received 09apr2019: patient allegedly received an implant on (b)(6) 2016 via the right internal jugular vein due to deep vein thrombosis and being high risk for blood clots-not anticoagulant candidate.Patient is alleging tilt, vena cava perforation, fracture, the device is unable to be retrieved and the filter is embedded in scar tissue.Per the (b)(6) 2016, retrieval report (attempted): "technique/findings: contrast was injected, and images were obtained.These images demonstrated the filter to be placed below the level of the renal veins but angled slightly with its apex/hook portion abutting the right inferior vena cava wall or possibly external to the vessel lumen.The pigtail catheter was removed and a 10 french sheath (included in the gunther tulip retrieval set) was advanced over the wire into the right internal jugular vein.The amplatz wire was exchanged for an 035 angled glidewire.An 80 cm sos catheter was placed over the glidewire and attempts were made to displace the apex/hook portion of the filter from the inferior vena cava wall but were unsuccessful.Additional attempts were made to snare the filter with a gooseneck amplatz snare, but this was not successful.The catheters were removed.Conclusion: unsuccessful attempt to retrieve the patient's cook celect inferior vena cava filter.Possible further intervention, potentially using laser ablation to separate the apex of the filter from the inferior vena cava wall, will be discussed with the patient".Patient outcome: patient alleges: "worries all the time that the device may break off and kill him.Has to be careful when doing leg workouts or heavy lifting".
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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.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.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, vena cava penetration.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.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.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.Unknown if the reported scar tissue and disability are directly related to the filter and unable to identify a corresponding failure mode at this point in time.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.The following allegations have been investigated: tilt, vc perforation, fracture, unable to be retrieved, embedment, scar tissue, disability.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.
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