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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-CELECT
Device Problems Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems Pain (1994); Perforation of Vessels (2135); Vomiting (2144); No Information (3190)
Event Date 05/15/2013
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog #: unknown but referred to as a cook celect filter. Expiration date: unknown as lot # is unknown. (b)(4). Since catalog # is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. Mfr date unknown as lot# is unknown. Investigation is still in progress.

 
Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a 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.

 
Manufacturer Narrative

(b)(4). Name and address for importer site: (b)(4). 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 receiving warranting supplementation in accordance with 21 c. F. R. 803. 56. Cook medical will continue to monitor for similar events.

 
Manufacturer Narrative

Manufacturer reference # (b)(4). Exemption number e2016032. (b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.

 
Event Description

This additional information received on 08/11/2017 as follows: patient allegedly received an implant on (b)(6) 2013 via the right common femoral vein due to pulmonary embolism and large left leg deep vein thrombosis. Patient is alleging vena cava perforation, pain, vomiting and hematoma due to the device. Patient alleges difficult but successful retrieval on (b)(6) 2013.

 
Manufacturer Narrative

Manufacturer reference # (b)(4). 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 'vena cava perforation, pain, vomiting, hematoma, difficult retrieval'. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. 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 vomiting, hematoma is directly related to the filter and unable to identify a corresponding failure mode 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.

 
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Brand NameCOOK CELECT NAVALIGN FEMORAL 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 Key6528745
MDR Text Key73896081
Report Number3002808486-2017-00979
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK090140
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 09/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/05/2017
Device Age4 mo
Event Location No Information
Date Manufacturer Received09/05/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2013
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: 04/28/2017 Patient Sequence Number: 1
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