COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
|
Back to Search Results |
|
Catalog Number IGTCFS-80-JUG |
Device Problem
Structural Problem (2506)
|
Patient Problems
Dyspnea (1816); Perforation of Vessels (2135); Chest Tightness/Pressure (2463)
|
Event Type
Injury
|
Manufacturer Narrative
|
Reporter occupation: non-healthcare professional.Investigation: the reported allegations have been further investigated based on the information provided to date.The following allegation has been investigated: vena cava perforation.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.A total of (b)(4) devices were manufactured in the reported lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device 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.
|
|
Event Description
|
The following information is alleged: the patient received a gunther tulip on (b)(6) 2004.The patient underwent a computed tomography (ct) scan of the abdomen and pelvis approximately 14 years later which revealed that the filter struts had moved since the filter was placed with several of the struts extending outside of the patient's inferior vena cava (ivc).Hospital and medical records have been requested, but not yet provided.
|
|
Manufacturer Narrative
|
Investigation: the following allegations have been investigated: chest pressure, dyspnea, physical limitations.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported chest pressure, dyspnea, and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.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.
|
|
Event Description
|
Patient allegedly received an implant via the right internal jugular vein due to pre bariatric surgery.Patient is alleging vena cava perforation.Patient notes and further alleges experiencing "chest pressure, shortness of breath" and physical limitations.Per the (b)(6) 2018 computed tomography (ct) abdomen: "some of the filter struts have penetrated through the wall of the ivc into the pericaval/mesenteric fat".
|
|
Search Alerts/Recalls
|
|
|