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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 Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135); Anxiety (2328); No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 09/20/2016
Event Type  Injury  
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 "vena cava perforation, tilt, embedded tip". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Unknown if the reported vena cava perforation, tilt, embedded tip is directly related to the filter and unable to identify a corresponding failure mode at this point in time. 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 tilt is a known potential complication of vena cava filters. Among other causes, filter tilt may be associated with placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e. G. , a surgical procedure in the vicinity of a filter) and (or) procedures that involve devices passing through a filter, or a failed retrieval attempt. Excessive filter tilt may result in loss of filter efficiency. Filter tilt is a known risk in relation to filter implant reported in the published scientific literature. Filter tilt may happen during placement or during implanting period.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation.
 
Event Description
It is alleged that "[pt] received a gunther tulip/gunther (1820334-2016-01442) tulip mreye (1820334-2016-01441) on (b)(6) 2006 at (b)(6) hospital in (b)(6). " it is alleged that the patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56.
 
Event Description
It is alleged that "[pt] received a gunther tulip (1820334-2016-01442)/ gunther tulip mreye (1820334-2016-01441) on (b)(6) 2006 at (b)(6). " it is alleged that the patient was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
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 12/29/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2006 via the right internal jugular vein due to bilateral lower extremity trauma with high risk of dvt. Plaintiff is alleging vena cava perforation, tilt, embedded tip with successful retrieval on (b)(6) 2016.
 
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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 Key6151827
MDR Text Key132586597
Report Number1820334-2016-01442
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,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 07/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
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 Received07/23/2017
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/07/2016 Patient Sequence Number: 1
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