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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-CELECT-PT
Device Problems Difficult or Delayed Positioning (1157); Difficult To Position (1467); Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog #: igtcfs-65-1-fem-celect-pt. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: "the physician went with the delivery sheath into the ivc. The sheath was advanced. The filter was unsheathed and it was deployed. The filter deployed sideways and none of the legs opened. None of the secondary or primary legs opened. The physician elected to utilize a snare in an attempt to grab the filter and pulled it down. This made the filter open into the ivc. The physician also had trouble getting the snare off the anchors of the filter; however with persistence, he was able to remove the snare. " patient outcome: the patient didn't have any adverse effects due to this occurrence.

 
Manufacturer Narrative

(b)(4). Catalog#: igtcfs-65-1-fem-celect-pt. (b)(4). Summary of investigational findings: only a venogram was provided and demonstrated 19° of leftward tilt and the proximal 10 mm of filter projected outside of column of contrast, meeting the definition of penetration. In addition, primary and secondary legs along the right appeared cranially displaced resulting in tenting of the right lateral ivc wall. The venogram did not explain the reason why "the filter deployed sideways and none of the legs opened", but the sheath may have been advanced either through the ivc wall or into a collateral vein. Potentially, the filter was deployed in extracaval location, as that would inhibit the filter legs from opening normally. After deployment a snare was utilized to pull the filter caudally, at which point the legs expanded into the ivc and consequently appeared cranially displaced. It is noted that the filter placement had no adverse effects on the patient. 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. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to initial reporter: the physician went with the delivery sheath into the ivc. The sheath was advanced. The filter was unsheathed and it was deployed. The filter deployed sideways and none of the legs opened. None of the secondary or primary legs opened. The physician elected to utilize a snare in an attempt to grab the filter and pulled it down. This made the filter open into the ivc. The physician also had trouble getting the snare off the anchors of the filter; however with persistence, he was able to remove the snare. Patient outcome: the patient didn't have any adverse effects due to this occurrence.

 
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Brand NameCOOK CELECT® PLATINUM 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 Key6217045
MDR Text Key63693082
Report Number3002808486-2016-01587
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2017
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-PT
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 Received12/20/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/14/2016
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: 01/02/2017 Patient Sequence Number: 1
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