Patient allegedly received an implant in (b)(6) 2014 via right femoral vein due to morbid obesity/gastric bypass.Patient is alleging vena cava perforation and tilt.The patient further alleges cramping in lower abdomen, worry about possible filter side effects and breakage (date of onset:2016).(b)(6) 2017, per a report from computed tomography (ct); ¿positive for caval perforation.Superior extent of caval filter l2-l3 disc space.Inferior extent mid l4 vertebral body.A total of 4 prongs have perforated the ivc.Maximum distance prongs perforated approximately 10mm.Coronal images approximately 0 degree tilt.Sagittal images 3 degree tilt posterior anterior.Diameter of ivc directly above filter 17x23mm.¿.
|
H6 device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation.Appropriate term/code not available (3191) was selected for the alleged device tilt.Investigation: the following allegations have been investigated: vena cava (vc) perforation, tilt, abdominal cramps, worry.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 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 abdominal cramps and worry are directly related to the filter and unable to identify a corresponding failure mode at this point in time.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.
|