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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 Filter (816); Break (1069); Material Fragmentation (1261); Material Perforation (2205)
Patient Problems Abdominal Pain (1685); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Lot# unknown as information was not provided. Catalog#: unknown ivc filter. Expiration date: unknown as the lot# is unknown. Since catalog# is unknown the 510(k) could be either k000855 or k032426 or k121057 or k061815 or k073374 or k090140 or k112119 or k121629 or k121057. Investigation is still in progress.

 
Event Description

Description of event according to complainant: doctor called in stating the patient's filter had a broken leg and other legs were perforating. Patient outcome: unknown as the information was not provided.

 
Manufacturer Narrative

Manufacturer ref# (b)(4). Igtcfs-65-1-fem-celect. (b)(4). Investigation is still in progress.

 
Event Description

Description of event according to complainant: doctor called in stating the patient's filter had a broken leg and other legs were perforating. Additional information received 28jul2016: "the broken celect finally came for removal. All of it could be removed. There was one broken side arm (not a hooked leg). This fragment was also successfully removed. We have a photograph of the filter available. Patient outcome: the patient had constant abdominal pain for 2 years with no relief. It instantly disappeared after removal and she was smiling in the recovery room having a meal, delighted with the result.

 
Manufacturer Narrative

(b)(4). Catalog#: igtcfs-65-1-fem-celect. (b)(4). Summary of investigational findings: imaging review confirms fracture of a secondary leg. X-ray images show the complete fracture of a secondary leg (oriented parallel to the long axis of the filter). The remaining primary and secondary legs appear intact and unremarkable. Insignificant tilt. No images of ivc filter placement or cross-sectional images available. Medical records states perforation of the ivc wall by multiple filter legs and the filter hook, however, imaging is not provided to support this. The root cause for the reported broken leg and other legs perforating the ivc wall cannot be determined. Given the information and the images provided, there are no predisposing factors, which may have contributed to the fracture or perforation of this filter. 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. Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature. There is found no evidence to suggest that this device was not manufactured according to specifications. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to complainant: doctor called in stating the patient's filter had a broken leg and other legs were perforating. Additional information received 28jul2016: "the broken celect finally came for removal. All of it could be removed. There was one broken side arm (not a hooked leg). This fragment was also successfully removed. We have a photograph of the filter available. Patient outcome: the patient had constant abdominal pain for 2 years with no relief. It instantly disappeared after removal and she was smiling in the recovery room having a meal, delighted with the result.

 
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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
4632 bjaeverskov
DA
Manufacturer Contact
marianne hoey
sandet 6
bjaeverskov 4632
DA   4632
56868686
MDR Report Key5719822
MDR Text Key48252673
Report Number3002808486-2016-00529
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/17/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2016
Is This An Adverse Event Report? No
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/16/2012
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: 06/13/2016 Patient Sequence Number: 1
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