Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported fear, increased anxiety, and depression are directly related to the filter and unable to identify a corresponding failure mode at this time.The following allegations have been investigated: fear, increased anxiety, depression.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.
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H6 device code(s): appropriate term/code not available (3191) was selected for the alleged device tilt.H6 device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava perforation, migration, tilt, pain, suffering.The reported allegations have been further investigated based on the information provided to date.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.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 , pain, and suffering are directly related to the filter and unable to identify a corresponding failure mode at this time.20 devices in lot.No other complaints on lot.Product is manufactured and inspected according to current controls.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 becomes 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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The patient further alleges vena cava perforation, tilt, migration, pain and suffering.Per a computerized tomography (ct) scan of the abdomen and pelvis dated (b)(6) 2019, ¿an ivc filter is in place with a strut extending beyond the ivc wall anteriorly which just contacts the serosal surface of the adjacent duodenum.Appearance is unchanged compared to prior study performed in 2018.Finding is most likely incidental and unlikely related to the patient's symptoms.¿ per a ct of the abdomen and pelvis dated (b)(6) 2019, ¿inferior vena cava filter is noted with the tip tilted to the right.Inferior struts project outside the caval lumen.On abuts the aortic wall.¿ per an interventional radiology (ir) vena cava filter removal operative report dated (b)(6) 2019, ¿successful and uneventful retrieval of a retrievable inferior vena caval filter.¿.
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