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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 Perforation of Vessels (2135); Stenosis (2263); Vascular System (Circulation), Impaired (2572)
Event Type  Injury  
Manufacturer Narrative

The previous mdr was submitted by (former manufacturer) under manufacturer report reference number 3002808486-2020-00689. Additional information provided determined that this device was manufactured by cook inc (cinc). With the submission of this initial report, cinc informs that all future submissions regarding this complaint will be handled under manufacturer report number referenced in of this initial medwatch report. Blank fields on this form indicate the information is unknown or unavailable. (b)(6). Investigation: the following allegations have been investigated: vena cava (vc) perforation, stenosis, filter obstruction/circulation issue, leg/foot pain, fear, anxiety, limited physical activity. 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 circulation issue, leg/foot pain, fear, anxiety, and limited physical activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time. 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. 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 on (b)(6) 2013 via the left common femoral vein due to a history of pulmonary embolism (pe) and deep vein thrombosis (dvt). Patient is alleging vena cava perforation and stenosis. Patient notes and further alleges experiencing "filter is clogged which is causing poor circulation to my lower extremities. Pain in leg and foot which hinder daily tasks and functions. Fear and anxiety filter is going to continue to cause internal damage that will result in death", limited physical activity. Per the (b)(6) 2019 computed tomography (ct) abdomen without contrast: "greenfield filter is noted with associated diffuse inferior vena cava stenosis and perforation of the struts. Extensive superficial subcutaneous varicosities throughout the abdominal wall most likely secondary to inferior vena cava obstruction".

 
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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 Key10330471
MDR Text Key201907753
Report Number1820334-2020-01366
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK043509
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/01/2016
Device MODEL NumberG33016
Device Catalogue NumberIGTCFS-65-FEM
Device LOT Number4245046
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/10/2013
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: 07/27/2020 Patient Sequence Number: 1
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