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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
Model Number G33016
Device Problems Obstruction of Flow (2423); Structural Problem (2506)
Patient Problems Chest Pain (1776); Perforation of Vessels (2135); Thrombosis/Thrombus (4440)
Event Type  Injury  
Manufacturer Narrative
The previous mdr was submitted by william cook europe under manufacturer report reference number (b)(4). Additional information provided determined that this device was manufactured by cook incorporated (cinc). With the submission of this initial report, cinc informs that all future submissions regarding this complaint will be handled under manufacturer report number of this initial medwatch report. Occupation: non-healthcare professional. Investigation: the following allegations have been investigated: vena cava perforation, dvt, chest/body pain, physical limitations. Investigation is reopened due to additional information provided. The reported allegations have been further investigated based on the information provided to date. 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 chest/body pain, physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time. A total of (b)(4) devices were manufactured in the reported lot. To date, one additional complaint has been reported against this lot (3557145). The associated work order was reviewed. No related/relevant notes were documented. The device is manufactured and inspected according to 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 report will be submitted should additional information become available.
 
Event Description
Patient allegedly received an implant (b)(6) 2012 via the left femoral vein due to an orthopedic procedure. Patient is alleging vena cava perforation. Patient notes and further alleges experiencing "pain throughout body and chest pains", physical limitations and post implant dvt. Per a computed tomography scan (ct) of the abdomen without contrast: "and ivc filter is identified which is seen straight along the course of the ivc. The proximal tip of the ivc filter is located at the level of the right renal vein, and just below the ostium of the left renal vein. There are 4 struts, without evidence of fracture. There is perforation of the left lateral strut, with its tip seen approximately 5 mm lateral to the ivc wall with abutment of the right lateral abdominal aortic wall. There is no significant narrowing of the ivc lumen at the level of the filter". Original: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2012. It is alleged that the [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided. ".
 
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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 Key11837502
MDR Text Key261530178
Report Number1820334-2021-01348
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043509
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 05/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2015
Device Model NumberG33016
Device Catalogue NumberIGTCFS-65-FEM
Device Lot Number3557145
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2012
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: 05/17/2021 Patient Sequence Number: 1
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