Patient allegedly received an implant via right common femoral vein due to deep vein thrombosis (dvt).Patient is alleging tilt, vena cava perforation, organ perforation and caval thrombosis.The patient further alleges chest pain and shortness of breath.Per a computerized tomography (ct) scan of the abdomen dated (b)(6) 2018, ¿the filter is tilted anteriorly.Its proximal cone has penetrated through the wall of the ivc into the pericaval/mesenteric fat.This may render the filter not retrievable.The filter legs have penetrated through the wall of the ivc into the pericaval/mesenteric fat.One of the filter legs has penetrated 1 cm into the anterior inferior corner of the l3 vertebra.This may render the filter nonretrievable.¿.
|
Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava/organ perforation, caval thrombosis, tilt, chest pain, dyspnea.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.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.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, dyspnea are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.No other complaints on lots.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.
|