Patient allegedly received an implant on (b)(6) 2012 via the right internal jugular vein due to deep vein thrombosis (dvt)/ pulmonary embolism (pe).Allegations include: vena cava perforation, chronic dvts; pes; anticoagulation post filter placement, pneumothorax, respiratory failure, and death.Further allegations inlude "shortness of breath (sob); fatigue; difficulty walking (wheelchair required for long distances); difficulty working and seeing patients (forced to sit more)".Patient reportedly expired (b)(6) 2019.Per x-ray report, "filter is seen external to the vena cava." per certificate of death, dated (b)(6) 2019: immediate cause of death: acute hypoxemic respiratory failure secondary to acute respiratory distress syndrome (ards), aspergillus pneumonia, pneumothorax.Other significant conditions: interstitial lung disease.
|
Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: death, pulmonary embolism (pe), vena cava (vc) perforation, chronic deep vein thrombosis (dvt)s, anticoagulation, pneumothorax, respiratory failure, sob, fatigue, limited mobility.The reported allegations have been further investigated based on the information provided to date.New pe 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: pulmonary embolism.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.Unknown if the reported death, anticoagulation, pneumothorax, respiratory failure, shortness of breath (sob), fatigue, and limited mobility are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot number are unknown, however, the alleged celect 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 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.
|