COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
|
Back to Search Results |
|
Catalog Number IGTCFS-65-JUG |
Device Problems
Obstruction of Flow (2423); Structural Problem (2506); Insufficient Information (3190)
|
Patient Problems
Internal Organ Perforation (1987); Thrombosis (2100); Perforation of Vessels (2135); No Information (3190)
|
Event Type
Injury
|
Manufacturer Narrative
|
Initial reporter occupation: non-healthcare professional.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog number and lot number are unknown, however, the alleged tulip 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
|
It is alleged that the patient received a gunther tulip on (b)(6) 2006.It is alleged that the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.
|
|
Event Description
|
Patient allegedly received an implant on (b)(6) 2006 due to blood clots.Patient is alleging organ/mesenteric perforation.The patient further alleges pain and post-implant deep vein thrombosis (dvt).It has been reported the patient expired.Per certificate of death dated (b)(6) 2019, "immediate cause of death was due to cardiopulmonary arrest with acute respiratory failure and metastatic pancreatic cancer listed as underlying causes.
|
|
Manufacturer Narrative
|
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: vc/organ/mesenteric perforation, deep vein thrombosis (dvt), pain.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 pain is directly related to the filter and unable to identify a corresponding failure mode at this point in time.10 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 become 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.
|
|
Manufacturer Narrative
|
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: b5, b6, h6.H6 conclusion code(s): appropriate term/code not available (4316) was selected because the previous investigation remains unchanged by the additional information.Investigation: investigation is reopened due to additional information provided.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this time.Cook will reopen the 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.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.
|
|
Event Description
|
Report from ct (computed tomography): "the filter is appropriately positioned with no evidence of tilt.The four struts are external to the ivc lumen.The anterior right strut is touching the wall of the duodenum.There is no evidence of perforation.The remaining struts are present within the fat surrounding the ivc.These struts extend 1.6 mm from the lumen.".
|
|
Manufacturer Narrative
|
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Conclusion code(s): appropriate term/code not available (d17) was selected because the previous investigation remains unchanged by the additional information.Investigation: investigation is reopened due to additional information provided.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this time.Cook will reopen the investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.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.
|
|
Event Description
|
No additional information at this time.
|
|
Search Alerts/Recalls
|
|
|