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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); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 07/01/2007
Event Type  malfunction  
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 "pt suffers from vena cava perforation, the inability to retrieve the device, and other: straightening of hook during removal attempt" cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Filter perforation of the vena cava wall is a known risk reported in the published scientific literature. Also, published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall. 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. From the published scientific literature filter tilt inside ivc and/or embedment of filter legs or filter hook in the ivc wall is a well-known risk. Several case reports published in articles, describe successful retrievals of such filters by advanced retrieval techniques. According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e. G. , the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu.
 
Event Description
Plaintiff allegedly received an implant on (b)(6) 2006 via the right common femoral vein due to le acute dvt, post-suicide attempt, multiple falls, poor candidate for anticoagulation, knee surgery. Plaintiff is alleging migration, device is unable to be retrieved, pain, nausea, vomiting. Plaintiff alleges attempted retrieval on (b)(6) 2006.
 
Manufacturer Narrative
Patient age at time of event is currently unknown. Patient sex at time of event is currently unknown. Date of event requested but not provided. Lot # requested but not provided. User facility information is currently unknown as this information was not provided. (b)(4). Device manufacture date is currently unknown as information was not provided. Investigation- no information regarding the event was provided to assist with the investigation. The investigation was based on the information received to date, and are closing the report until further information is received for investigation. It is impossible to comment on alleged injuries. No evidence to suggest a device failure. No conclusion could be drawn.
 
Event Description
It is alleged that patient received a cook gunther tulip filter on (b)(6) 2006. The filter was placed by dr. (b)(6) at (b)(6) hospital; (b)(6). It is alleged that patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). Investigation - no information regarding the event has been provided. We have investigated based on the information received to date and are closing the report until further information is received for investigation. Impossible to comment on alleged injuries. If additional information is received, the report will be re-opened for further investigation. There is no evidence to suggest the device was not manufactured to specifications. No evidence to suggest a device failure. The evaluation will be reassessed when further information is available.
 
Event Description
It is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2006. The filter was placed by dr. (b)(6) at (b)(6) hospital; (b)(6). It is alleged that patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). Instructions for filter retrieval are labeled in the ifu. The event is currently under investigation. A supplemental report will be submitted upon completion.
 
Event Description
Additional information received (b)(6) 2017: it is alleged in the pending lawsuit that pt suffers from migration and the inability to retrieve the device.
 
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 03/15/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2006 via the right common femoral vein due to le acute dvt, post-suicide attempt, multiple falls, poor candidate for anticoagulation, knee surgery. Plaintiff is alleging migration, device is unable to be retrieved, pain, nausea, vomiting. Plaintiff alleges attempted retrieval on (b)(6) 2007.
 
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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 Key5471099
MDR Text Key196701012
Report Number1820334-2016-00114
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 Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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? No
Event Location Other
Date Manufacturer Received06/25/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/01/2008
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: 03/01/2016 Patient Sequence Number: 1
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