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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 Structural Problem (2506); Device Tipped Over (2589); Difficult to Open or Close (2921)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135)
Event Type  Injury  
Manufacturer Narrative

The previous mdr was submitted by william cook europe under manufacturer report reference number 3002808486-2020-00348. 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 this initial medwatch report. Reporter occupation: non-healthcare professional. Investigation: investigation is reopened due to additional information provided. Vena cava (vc) perforation, embedded, tilt, and not fully expanded. 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. 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. It is unknown if the reported not fully expanded filter is 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, two other complaints have been reported against the lot, pr157911, pr226865. 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 report will be submitted should additional information become available.

 
Event Description

Patient allegedly received an implant on (b)(6) 2014 via the right groin due to prevention of deep vein thrombosis (dvt)/pulmonary embolism (pe). Patient is alleging device tilt, vena cava perforation and embedment. Per the (b)(6) 2014 x-ray: "fluoroscopic guidance obtained during placement of an ivc filter. The filter as [sic] not appear to be fully expanded after placement which is of uncertain significance". Per an (b)(6) 2018 computed tomography (ct) abdomen2: "a filter is tilted posteriorly. Its proximal cone lies on the wall of the ivc possibly embedded in it. The filter legs have penetrated through the wall of the ivc into the pericaval/mesenteric fat".

 
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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 Key10072364
MDR Text Key194479666
Report Number1820334-2020-00963
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 05/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/01/2016
Device MODEL NumberG33016
Device Catalogue NumberIGTCFS-65-FEM
Device LOT Number4360058
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/06/2013
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: 05/19/2020 Patient Sequence Number: 1
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