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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
Model Number N/A
Device Problems Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135); No Information (3190); No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
Investigation - evaluation: 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 'tilt, vena cava perforation, difficulty breathing while laying down'. 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 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. 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. Unable to determine if the reported difficulty breathing while laying down is related to the filter and unable to determine a corresponding failure mode. 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 provided upon conclusion.
 
Event Description
This additional information received on 02/jan/2018 as follows: patient received an implant on (b)(6) 2009 via the right common femoral vein due to deep vein thrombosis. Patient is alleging device tilt, vena cava perforation and difficulty breathing while laying down due to the device. It is alleged that the plaintiff received a gunther filter on (b)(6) 2009. It is alleged that the plaintiff was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
Additional information: investigation: investigation is reopened due to additional information provided. The reported allegations have been further investigated based on the information provided to date. The following allegations have been investigated: embedment. 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. A filter that is embedded in the wall of the ivc may be difficult to retrieve. For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth. Catalogue and lot# are unknown, but the tulip filter is manufactured and inspected according to specifications. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
Patient alleges embedment. Per ct, (b)(6) 2017: " slight tilting with top just below the opening of the left renal vein. Four legs puncture through the wall of the ivc. ".
 
Manufacturer Narrative
The event is currently under investigation. A supplemental report will be submitted upon completion.
 
Event Description
It is alleged that the plaintiff received a gunther filter on (b)(6) 2009. 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 (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7151946
MDR Text Key195839622
Report Number1820334-2017-04654
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 05/15/2019
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? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot 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 Received05/01/2019
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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