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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 N/A
Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)
Patient Problems Erosion (1750); Pain (1994); Perforation (2001)
Event Date 02/08/2010
Event Type  Injury  
Manufacturer Narrative
(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 12/02/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2010 via the right common femoral vein due to deep vein thrombosis and pulmonary emboli. Plaintiff is alleging device migration, tilt, vena cava perforation, erosion of vertebral body, lower back pain, decreased range of motion, sleeplessness. Plaintiff alleges attempted retrieval on (b)(6) 2010 and (b)(6) 2010 and successful retrieval on (b)(6) 2014.
 
Manufacturer Narrative
It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'tulip, migration, tilt, vena cava perforation, diff remove, erosion of vertebral body, pain'. Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement. Vena cava wall perforation is a known potential complication of vena cava filters. Both symptomatic and asymptomatic events have been reported. Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e. G. , a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter. There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae. E. G. Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae. In contrast, perforation of adjacent organs is reported with clinical sequelae. Filter retrieval is occasionally difficult. This is well-known from published scientific literature where filter retrievals are referred to as simple vs. Complex. Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques. Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period. There is 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.
 
Manufacturer Narrative
(b)(4). Investigation is based on the limited information in the event description (maude report mw5037141) since no clinical imaging or device is returned. Patient's medical records are unknown, therefore details related to filter implant procedure are unknown and pain onset date unknown. Unable to comment on perforations and unsuccessfully retrieval attempts and need for a "fourth surgery" without clinical images. However, filter perforation of the vena cava wall is a well known risk in published medical scientific literature. Also literature describes different retrieval techniques used for difficult retrievals. A reference is made to the potential adverse events in the instructions for use. No evidence to suggest that this device was not manufactured according to specifications. Based on limited information unable to determine the exact root cause for this event. Updated on 15mar2016: complaint reopened since lot was provided. No relevant notes on work order, nor on filter lot 1654279. 4. No other complaint has been registered under this lot. Gunther tulip femoral vena cava filter set manufactured/inspected according to specifications. No other additional information received at the moment, but if additional information is received, the report will be reopened for further investigation. Until then investigation preciously submitted is still valid and remains unchanged.
 
Event Description
A male unknown age underwent an ivc filter placement on (b)(6) 2010. The filter was supposed to be a retrievable temporary filter. However, the filter was unsuccessfully removed. The patient has been suffering from pain since 2010. The filter has now perforated the ivc and touching the vertebrae. The patient is awaiting the means of getting the device removed. The patient's medical records show the cook gunther tulip was defective and requires a fourth surgery to have the device removed from the ivc. A fourth surgery was required to have the device removed from the ivc.
 
Manufacturer Narrative
Initial mdr was submitted by william cook europe under reference # 3002808486-2014-00062. Additional information provided on 09mar2016 determined this device was manufactured by cinc. Supplemental mdr# 1820334-2016-00183. Investigation is based on the limited information in the event description (maude report mw5037141) since no clinical imaging or device is returned. Patient's medical records are unknown, therefore details related to filter implant procedure are unknown and pain onset date unknown. Unable to comment on perforations and unsuccessfully retrieval attempts and need for a "fourth surgery" without clinical images. However, filter perforation of the vena cava wall is a well known risk in published medical scientific literature. Also literature describes different retrieval techniques used for difficult retrievals. A reference is made to the potential adverse events in the instructions for use. No evidence to suggest that this device was not manufactured according to specifications. Based on limited information unable to determine the exact root cause for this event. Updated on 15mar2016 : complaint reopened since lot was provided. No relevant notes on work order, nor on filter lot 1654279. 4. No other complaint has been registered under this lot. Gunther tulip femoral vena cava filter set manufactured/inspected according to specifications. No other additional information received at the moment, but if additional information is received, the report will be reopened for further investigation. Until then investigation preciously submitted is still valid and remains unchanged.
 
Event Description
A male unknown age underwent an ivc filter placement on (b)(6) 2010. The filter was supposed to be a retrievable temporary filter. However, the filter was unsuccessfully removed. The patient has been suffering from pain since 2010. The filter has now perforated the ivc and touching the vertebrae. The patient is awaiting the means of getting the device removed. The patient's medical records show the cook gunther tulip was defective and requires a fourth surgery to have the device removed from the ivc. A fourth surgery was required to have the device removed from the ivc.
 
Manufacturer Narrative
William cook europe initially reported event under mfr report # 3002808486-2014-00062. New information was received identifying that the product was a cook inc. Manufactured device. An updated emdr report was submitted under cook inc. Mfr report # 1820334-2016-00183, follow up # 2. This was in reference to william cook europe mfr report # 3002808486-2014-00062. Cook is now submitting an initial report to correct this issue. (b)(4). Investigation- investigation is based on the limited information in the event description (maude report mw5037141) since no clinical imaging or device is returned. Patient's medical records are unknown, therefore details related to filter implant procedure are unknown and pain onset date unknown. Unable to comment on perforations and unsuccessfully retrieval attempts and need for a "fourth surgery" without clinical images. However, filter perforation of the vena cava wall is a well known risk in published medical scientific literature. Also literature describes different retrieval techniques used for difficult retrievals. A reference is made to the potential adverse events in the instructions for use. No evidence to suggest that this device was not manufactured according to specifications. Based on limited information unable to determine the exact root cause for this event. Updated on 15mar2016 : complaint reopened since lot was provided. No relevant notes on work order, nor on filter lot 1654279. 4. No other complaint has been registered under this lot. Gunther tulip femoral vena cava filter set manufactured/inspected according to specifications. No other additional information received at the moment, but if additional information is received, the report will be reopened for further investigation. Until then investigation preciously submitted is still valid and remains unchanged.
 
Event Description
A male unknown age underwent an ivc filter placement on (b)(6) 2010. The filter was supposed to be a retrievable temporary filter. However, the filter was unsuccessfully removed. The patient has been suffering from pain since 2010. The filter has now perforated the ivc and touching the vertebrae. The patient is awaiting the means of getting the device removed. The patient's medical records show the cook gunther tulip was defective and requires a fourth surgery to have the device removed from the ivc. A fourth surgery was required to have the device removed from the ivc.
 
Manufacturer Narrative
The event is currently under investigation. A supplemental report will be submitted upon completion.
 
Event Description
As reported under mw5037141: a male unknown age underwent an ivc filter placement on (b)(6) 2010. The filter was supposed to be a retrievable temporary filter. However, the filter was unsuccessfully removed. The patient has been suffering from pain since 2010. The filter has now perforated the ivc and touching the vertebrae. The patient is awaiting the means of getting the device removed. The patient's medical records show the cook gunther tulip was defective and requires a fourth surgery to have the device removed from the ivc. A fourth surgery was required to have the device removed from the ivc. Additional information received january 30, 2017: it is alleged in the pending lawsuit that pt suffers from migration, tilt, vena cava perforation, and other: erosion into vertebral body.
 
Manufacturer Narrative
Investigation- the investigation results previously submitted are still valid and remain unchanged. Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56. Investigation is based on the limited information in the event description (maude report mw5037141) since no clinical imaging or device is returned. Patient's medical records are unknown, therefore details related to filter implant procedure are unknown and pain onset date unknown. Unable to comment on perforations and unsuccessfully retrieval attempts and need for a "fourth surgery" without clinical images. However, filter perforation of the vena cava wall is a well known risk in published medical scientific literature. Also literature describes different retrieval techniques used for difficult retrievals. A reference is made to the potential adverse events in the instructions for use. No evidence to suggest that this device was not manufactured according to specifications. Based on limited information unable to determine the exact root cause for this event. Updated on 15mar2016 : complaint reopened since lot was provided. No relevant notes on work order, nor on filter lot 1654279. 4. No other complaint has been registered under this lot. Gunther tulip femoral vena cava filter set manufactured/inspected according to specifications.
 
Event Description
As reported under mw5037141: a male unknown age underwent an ivc filter placement on (b)(6) 2010. The filter was supposed to be a retrievable temporary filter. However, the filter was unsuccessfully removed. The patient has been suffering from pain since 2010. The filter has now perforated the ivc and touching the vertebrae. The patient is awaiting the means of getting the device removed. The patient's medical records show the cook gunther tulip was defective and requires a fourth surgery to have the device removed from the ivc. A fourth surgery was required to have the device removed from the ivc. Additional information received january 30, 2017: it is alleged in the pending lawsuit that pt suffers from migration, tilt, vena cava perforation, and other: erosion into vertebral body.
 
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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 Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key5640445
MDR Text Key107749915
Report Number1820334-2016-00183
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 Patient
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberIGTCFS-65-FEM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location Other
Date Manufacturer Received06/29/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/01/2012
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: 05/09/2016 Patient Sequence Number: 1
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