COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
|
Back to Search Results |
|
Model Number G33016 |
Device Problems
Structural Problem (2506); Device Tipped Over (2589)
|
Patient Problems
Internal Organ Perforation (1987); Pain (1994); Anxiety (2328); Discomfort (2330); Depression (2361)
|
Event Type
Injury
|
Manufacturer Narrative
|
The previous mdr was submitted by william cook europe under manufacturer report reference# #3002808486-2021-01238.Additional information provided determined that this device was manufactured by cook inc (cinc).With the submission of this initial report, cinc informs that all future submissions regarding this complaint will be handled under manufacturer report number referenced in this initial medwatch report.Occupation: non-healthcare professional investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: organ perforation and tilt.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.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 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 become available.
|
|
Event Description
|
Patient allegedly received an implant on (b)(6) 2012 due to trauma surgery/motor vehicle accident.Patient is alleging tilt, and organ perforation.Report from computerized tomography (ct): "tilting with apex against the ivc wall - 5 mm small bowel, and 5 mm mesenteric perforation - no fracture, stenosis, or migration".
|
|
Event Description
|
Patient additionally alleges "pain, discomfort, anxiety," depression, and "i have to constantly wear oxygen".
|
|
Manufacturer Narrative
|
Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: pain, discomfort, anxiety, depression, supplemental oxygen.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported pain, discomfort, anxiety, depression, and supplemental oxygen are is directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of (b)(4) 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.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.
|
|
Search Alerts/Recalls
|
|
|