Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrected information: d5 additional information: a2, a4, b1, b5, b6, b7, d1, d4, g5, h4, h6 (patient and device codes) h6 (device code): appropriate term/code not available (3191) for perforation h6 (device code): appropriate term/code not available (3191) for device tilt investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: organ perforation, tilt, migration, chest pain, feet swelling, stress, anxiety, mental anguish and limited exercise ability.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 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 chest pain, feet swelling, stress, anxiety, mental anguish and limited exercise ability is 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." 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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Update (b)(6)2019: patient allegedly received an implant on (b)(6)2015 via the right internal jugular vein due to deep vein thrombosis (dvt) right leg.Patient is alleging tilt, vena cava and organ perforation.Patient notes and further alleges experiencing "constant chest pain, foot swelling, in both feet, anxiety, mental anguish and stress about the status of my filter and any related injuries" and limited ability to exercise.Additionally, migration has been reported in the review of the (b)(6)2017 computed tomography (ct) report.Per the (b)(6)2015 ivc (inferior vena cava) filter placement: "findings: successful deployment of a infrarenal ivc filter with the hook in the renal vein confluence.Subsequent digital subtraction venography demonstrates excellent position of the ivc filter without tilt".Per a review of the (b)(6)2017 ct abdomen report: "the inferior vena cava filter is seen in the infrarenal location.The superior margin is slightly tilted/slightly angulated slightly anteriorly and is adjacent to the anterior wall of the inferior vena cava.The inferior filler struts show evidence of migration beyond the inferior vena caval wall.All 4 struts appear lo extend slightly beyond the inferior vena cava wall, most noted on the left posterior inferior vena cava filter strut which extends at least 3 or 4 mm posterior to the wall the inferior vena cava, and approximately 6 mm in the craniocaudal dimension.The anterior aspect of the adjacent l3 vertebral body in the adjacent region shows a small region of sclerosis and indentation suggesting potential small region of pressure erosion and bony remodeling from the inferior vena cava filter stent.The right posterior inferior vena cava filter strut also extends well beyond the margin of the inferior vena cava with craniocaudal migration measuring at least 6 mm and is best appreciated on coronal reconstruction image 31 of series 4.There is no adjacent inflammatory change.The inferior vena cava beyond the level the stent does not appear to have any stenosis".
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