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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problems Occlusion Within Device (1423); Insufficient Information (3190)
Patient Problems Congestive Heart Failure (1783); Occlusion (1984); Swelling (2091); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
This additional information received on 09feb2018 as follows: pt allegedly received an implant on (b)(6) 2007 via the right internal jugular vein due to history of left lower extremity deep venous thrombosis. Pt is alleging device is unable to be retrieved, occlusion of the ivc and bilateral iliac veins, underwent recannulization of the chronic occlusion, balloon angioplasty, and stent placement, failed retrieval attempt, severe swelling of the legs with congestive venous symptoms, venous collaterals along the abdominal wall and thoracic chest wall. Additionally the patient alleges extreme difficulty walking, congestive heart failure and diminished lung capacity. Retrieval was attempted (unsuccessful) on (b)(6) 2016.
 
Manufacturer Narrative
Additional information: investigation - 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, unable to retrieve, icv occlusion, leg swelling, difficulty walking, congestive heart failure'. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. 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. Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature. Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic. Unknown if the reported difficulty walking, leg swelling, and congestive heart failure is directly related to the filter and unable to identify corresponding failure mode(s) at this time. 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
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 ¿gunther tulip filter implanted". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. 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). The event is currently under investigation. A supplemental report will be submitted upon completion.
 
Event Description
It is alleged the patient received a gunther tulip filter implanted on or about (b)(6) 2007. It is alleged that the plaintiff was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
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Brand NameUNKNOWN
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 Key7152004
MDR Text Key253830365
Report Number1820334-2017-04674
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 04/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
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 Received03/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/28/2017 Patient Sequence Number: 1
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