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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-JUG-CELECT
Device Problems Difficult to Remove (1528); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pain (1994); Cramp(s) (2193); No Information (3190)
Event Date 08/27/2013
Event Type  malfunction  
Manufacturer Narrative
Manufacturer reference # (b)(4). Exemption number e2016032. William cook (b)(5) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer). (b)(4). Registration no. : (b)(4). Corrected data based on new information received: adverse event to product malfunction. Serious injury to malfunction. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 07/19/2017 as follows: patient allegedly received an implant on (b)(6) 2013 via the right internal jugular vein due to deep vein thrombosis. Patient is alleging pain, weight loss, and cramps due to the device. Patient alleges that the device is tilted, embedded and is unable to be retrieved. Patient alleges attempted retrieval on (b)(6) 2013.
 
Manufacturer Narrative
Exemption number e2016032. (b)(4). 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 'pain, weight loss, cramps, device tilt, embedded and unable to be retrieved'. 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. 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. Unknown if the reported weight loss and cramps 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
(b)(4). Catalog#: unknown but referred to as a cook celect filter. Name and address for importer site: (b)(4). Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2013". Patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
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Brand NameNAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
400 daniels way
bloomington, IN 47404
8004574500
MDR Report Key6727288
MDR Text Key208706732
Report Number3002808486-2017-01546
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090140
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 09/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-1-JUG-CELECT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date07/07/2017
Device Age6 MO
Event Location No Information
Date Manufacturer Received09/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/01/2013
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: 07/20/2017 Patient Sequence Number: 1
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