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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 Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Anxiety (2328); No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged. Additional information: 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. 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
Information previously submitted by (b)(4) under reference # 3002808486-2016-01205. Additional information provided on 11/16/2016 determined this device was manufactured by (b)(4). The event is currently under investigation.
 
Event Description
Description according to short form complaint filled: it is alleged that "[pt] received a cook celect filter on (b)(6) 2009. " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). 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. It has not been possible to fully investigate or evaluate this event based on the limited information provided to date. Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56.
 
Event Description
Description according to short form complaint filled: it is alleged that "[pt] received a cook celect filter on (b)(6) 2009. " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
Corrected event description. Device manufacture date) date corrected.
 
Event Description
Plaintiff allegedly received an implant on (b)(6) 2009 via the groin due to following a car accident. Plaintiff is alleging anguish/anxiety that filter has failed or will fail causing additional medical problems.
 
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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 Key6155986
MDR Text Key109675147
Report Number1820334-2016-01445
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
Report Date 07/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2016
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?
Event Location No Information
Date Manufacturer Received06/26/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/17/2009
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: 12/08/2016 Patient Sequence Number: 1
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