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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 Migration or Expulsion of Device (1395); Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems Pain (1994); Perforation of Vessels (2135); Palpitations (2467); No Information (3190)
Event Date 10/09/2014
Event Type  malfunction  
Manufacturer Narrative
Unknown if the following patient and device codes are listed in the ifu. Product information not provided. Corrected data based on new information received: adverse event to product problem. Serious injury to malfunction. The event is currently under investigation. A supplemental report will be provided upon conclusion. This report is required by the fda under 21 cfr part 803. This report is based on unconfirmed information submitted by others. Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred. Other text : unknown if the following patient and device codes are listed in the ifu. Product information not provided. (b)(4) corrected data based on new information received: adverse event to product problem. Serious injury to malfunction. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information was received on 06/16/2017 as follows: the plaintiff allegedly received the filter implant on (b)(6) 2003 due to dvt following a motor vehicle accident. Unsuccessful retrieval attempts allegedly occurred on (b)(6) 2014, (b)(6) 2015. The plaintiff alleges vena cava perforation, migration, device unable to be retrieved, heart palpitations, and pain.
 
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; migration; device unable to be retrieved; heart palpitations; pain'. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement. 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 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. Unknown if the reported heart palpitations, depression and pain is directly related to the filter and unable to identify corresponding failure mode(s) at this time. 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.
 
Event Description
The pt allegedly received the filter implant on (b)(6) 2003 due to deep vein thrombosis (dvt) following a motor vehicle accident. Unsuccessful retrieval attempts allegedly occurred on (b)(6) 2014. The plaintiff alleges vena cava perforation, migration, device unable to be retrieved. The pt further alleges, depression, heart palpitations, and pain.
 
Manufacturer Narrative
The event is currently under investigation. A supplemental report will be submitted upon completion.
 
Event Description
It is alleged that [pt] received a cook gunther tulip on (b)(6) 2003. It is alleged that the patient 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 Key6615486
MDR Text Key195838123
Report Number1820334-2017-01336
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
Report Date 01/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received12/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/06/2017 Patient Sequence Number: 1
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