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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); Detachment of Device or Device Component (2907)
Patient Problems Chest Pain (1776); Pain (1994); Perforation of Vessels (2135); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative

Initial reporter occupation: non-healthcare professional. Investigation: the reported allegations have been further investigated based on the information provided to date. The following allegations have been investigated: fracture, vena cava perforation/ "grade 3 perforation of 6:00 strut to abut anterior osteophyte between l3-l4", 3 post-implant deep vein thrombosis (dvt)'s, tilt, leg pain/ swelling/ cramps, darkening of the skin (lower legs, ankles, feet), low blood flow in left leg/ right arm, consistent back pain, chest pain, wearing support stockings every day due to swelling/ poor [lack of] blood flow, and inability to work/ squat/ raise left leg/ "be on" legs long without swelling. Filter fracture has been reported and may be either symptomatic or asymptomatic. Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e. G. , a renal vein). Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter). Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported. Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures. 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. 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. Unknown if the reported leg pain/ swelling/ cramps, darkening of the skin (lower legs, ankles, feet), low blood flow in left leg/ right arm, consistent back pain, chest pain, wearing support stockings every day due to swelling/ poor [lack of] blood flow, and inability to work/ squat/ raise left leg/ "be on" legs long without swelling are directly related to the filter and unable to identify a corresponding failure mode at this point in time. 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.

 
Event Description

It is alleged that the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2008 via the right common femoral vein due to deep vein thromboses (dvts). The patient is alleging fracture, vena cava perforation/ "grade 3 perforation of 6:00 strut to abut anterior osteophyte between l3-l4", and tilt. The patient is further alleging leg pain/ swelling/ cramps, darkening of the skin (lower legs, ankles, feet), low blood flow in left leg/ right arm, consistent back pain, chest pain, 3 dvts post ivc filter placement, wearing support stockings every day due to swelling/ poor [lack of] blood flow, and inability to work/ squat/ raise left leg/ "be on" legs long without swelling.

 
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Brand NameGUNTHER TULIP FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK 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 Key11641755
MDR Text Key244655818
Report Number1820334-2021-01108
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
PMA/PMN NumberK043509
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 04/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/01/2011
Device Catalogue NumberIGTCFS-65-FEM
Device LOT Number2093934
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/09/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/09/2021 Patient Sequence Number: 1
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