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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-FEM
Device Problems Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Unintended Movement (3026)
Patient Problems Occlusion (1984); Internal Organ Perforation (1987); Perforation of Vessels (2135); Anxiety (2328); Thrombosis/Thrombus (4440)
Event Type  Injury  
Manufacturer Narrative
Information provided by (b)(6).Occupation: non-healthcare professional.Investigation: 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.This report includes information known at this time.A follow up report will be submitted should additional information become available.
 
Event Description
It is alleged that the patient received a cook gunther tulip filter and is alleging post implant clots.Hospital and medical records have not been provided.
 
Manufacturer Narrative
Additional information: investigation: the investigation was 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: vena cava/adjacent structure perforation and post implant clots.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.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.A total of 10 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 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.
 
Event Description
Additional information received alleges that the patient experienced perforation of the inferior vena cava (ivc) by the struts of the ivc filter, with perforating struts also perforating into adjacent structures.
 
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: 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, migration, tilt, anxiety, worry, fear, limited physical activity, the additional information regarding organ perforation does not change the previous investigation results for vena cava perforation.Filter or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; 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: filter migration, trauma to adjacent structures.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.Unknown if the reported anxiety, worry, fear, and limited physical activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.10 devices in lot.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 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.
 
Event Description
Patient allegedly received an implant on (b)(6) 2006 via the right common femoral vein due to trauma.Patient is alleging vena cava and organ perforation.Patient further alleges anxiety, worry, fear, limited physical activity.Report from ct (computed tomography): "caval perforation: yes.6 o'clock 4.5 mm extending into the l3 vertebral body.Tilt: yes.Left-sided tilt 5.32 degrees.Migration: yes.Apex of the caval filter is at the level of the origin of the renal veins pertinent negatives: none.Additional findings: none.".
 
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Brand Name
GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
Type of Device
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key11390057
MDR Text Key234222987
Report Number1820334-2021-00518
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K043509
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 11/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/01/2008
Device Catalogue NumberIGTCFS-65-FEM
Device Lot Number1514536
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/01/2021
Initial Date FDA Received02/27/2021
Supplement Dates Manufacturer Received08/10/2022
10/18/2022
Supplement Dates FDA Received09/08/2022
11/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2005
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient SexFemale
Patient Weight73 KG
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