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U.S. Department of Health and Human Services

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

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COOK INC GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G21360
Device Problems Structural Problem (2506); Device Tipped Over (2589)
Patient Problems Perforation of Vessels (2135); Anxiety (2328)
Event Type  Injury  
Manufacturer Narrative

The previous medwatch report was submitted by william cook europe under manufacturer report reference# 3002808486-2021-01239. Initial report occupation - non-healthcare professional. Additional information provided determined that this device was manufactured by cook inc. With the submission of this initial medwatch report, cook inc. Informs that all future submissions regarding this complaint will be handled under the manufacturer report reference # referenced in this initial medwatch report. 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: vena cava perforation/aorta abutment, tilt, anxiety, worry. 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. Unknown if the reported anxiety and worry are directly related to the filter and unable to identify a corresponding failure mode at this point in time. (b)(4) 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. 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 a cook gunther tulip implant on (b)(6) 2015 via the right internal jugular vein due to deep vein thrombosis (dvt). Patient is alleging vena cava perforation and aorta abutment. The patient further alleges anxiety and worry. Report from ct (computed tomography): "there is an ivc filter in place. The tip of the filter ends at the l2-3 level. This is below the level of the renal veins. There are 4 struts. The filter appears to be normal in alignment on the coronal images. On sagittal images, there is a tilt of the upper filter posteriorly. The degree of angulation measures approximately 10 degrees. All 4 of the struts protrude through the walls of the ivc into the adjacent tissues. The left lateral strut abuts the right lateral wall of the aorta. No obvious protrusion through the wall is appreciated. The appearance is consistent with a grade 2-3 perforation. The remaining struts project into fatty tissues adjacent to the ivc consistent with grade 2 perforations. No fractured struts are seen. There is no obvious clot formation within the ivc. The remainder of the examination is unremarkable. ".

 
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Brand NameGUNTHER TULIP JUGULAR & 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 Key12385768
MDR Text Key269352577
Report Number1820334-2021-02078
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/01/2015
Device MODEL NumberG21360
Device Catalogue NumberIGTCFS-65-UNI
Device LOT Number4704511
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2013
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: 08/30/2021 Patient Sequence Number: 1
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