The patient received an implant on (b)(6) 2014 via the right common femoral vein due to venous thrombosis(vt)/pulmonary embolism (pe).(b)(6) 2018, per a report from computed tomography; ¿an ivc filter is present with apex at l2 at the level of the renal vein, struts inferior l3 level, with upper tip at the level of the left renal vein.The filter has no significant anterior tilt.Five of the struts extend outside the ivc wall, one medially in the posterior paraaortic space with the strut extending 8mm, one anteromedially 12mm, one laterally into adjacent retroperitoneal fat with strut extending 6mm inferiorly; one posteriorly, 4mm.Lastly an anterolateral strut extends 5mm into adjacent fat.No strut fractures are seen and none appear bent.¿.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: a2, b1, b5, b7, and h6.Investigation: the following allegations have been investigated: vena cava (vc) perforation.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.Catalog number and lot number are unknown, however, the alleged celect is manufactured and inspected according to 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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