Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: the following allegations have been investigated: vena cava perforation and migration.Investigation is reopened due to additional information provided.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.20 devices in lot.No relevant notes on work order.The 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 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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Patient allegedly received an implant on (b)(6) 2013 due to deep vein thrombosis and pulmonary embolism followed by a successful percutaneous retrieval via sheath access through right internal jugular vein on (b)(6) 2018 due to filter perforating the vein.The patient alleges migration, vena cava perforation.(b)(6) 2018, per a report from (successful); ¿impression: successful inferior vena cava filter removal.¿ "there is no thrombus identified within the filter or within the inferior vena cava".(b)(6) 2019, per a report from radiology; ¿[the patient] underwent placement of a cook celect ivc filter on (b)(6) 2013.No imaging studies were provided demonstrating filter placement.Ct abdomen/pelvis performed on (b)(6) 2014 demonstrates the filter at the inferior l2 to superior l4 interspace.Migration is possible based on the study.There is no significant tilt indicated, 10 degrees to the left along the coronal plane.A grade 3 perforation is demonstrated.Two ventral struts extend 4mm outside the cava wall abutting the small bowel.A posterior strut extends 4mm outside the cava wall and abuts the anterosuperior l4 vertebrae.An abdominal x-ray performed on (b)(6) 2015 demonstrates the filter at the inferior l2 to superior l4 interspace.A cavagram performed on (b)(6) 2018 demonstrates a successful retrieval and removal of the filter.¿.
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