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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-2-UNI-CELECT-PT
Device Problems Occlusion Within Device (1423); Difficult to Remove (1528); Malposition of Device (2616); Appropriate Term/Code Not Available (3191)
Patient Problems Perforation of Vessels (2135); No Known Impact Or Consequence To Patient (2692)
Event Date 08/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Catalog#: igtcfs-65-2-uni-celect-pt. Similar to device with 510(k) k121629. Investigation is still in progress.
 
Event Description
Description of event according to study: during the index procedure on (b)(6) 2016, the patient received a celect® filter. The inferior vena cava (ivc) diameter at the intended filter location was 28 mm. There was no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement. Using the right common femoral vein as the access site, a celect® filter was deployed at the intended location in the ivc infrarenal site and in a location suitable to provide sufficient mechanical protection against pe. The filter neither deployed prematurely nor did the filter jump upon deployment. There was no evidence of filter fracture, deformation, or migration. Filter tilt was 11-< 16 degrees. There was no extravasation of contrast or filter legs appearing outside the column of contrast after filter placement. Analysis of the placement procedure venacavagram revealed no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement. The filter was placed in the ivc infrarenal site and the ivc diameter was 23. 4 mm. There was no evidence of filter migration, extravasation of contrast, or deformation. Filter legs did appear outside the column of contrast after filter placement. The angle of filter tilt in the ap view was 14. 3 degrees. On (b)(6) 2016 (68 days post-procedure), the filter removal was attempted because it was no longer clinically needed. The amount of thrombus present in the filter has not been provided yet. Filter legs did appear outside the column of contrast before retrieval. Retrieval was attempted with a gunther tulip retrieval set via the right internal jugular vein. Additional methods/devices included a right common femoral vein access with wire snare and balloon dilatation to displace filter tip. The physician reported major difficulty retrieving the ivc filter. The filter was not successfully retrieved for the following reasons: hook oriented towards vessel wall. Hook embedded in vessel wall and unable to grasp. Patient outcome: the patient was discharged on (b)(6) 2016. The patient remains in the study.
 
Manufacturer Narrative
(b)(4). Catalog#: igtcfs-65-2-uni-celect-pt. Similar to device under 510(k) k121629. Summary of investigational findings: imaging review confirmed tilt, perforation and the difficulties with filter retrieval. The filter tilted during the placement procedure. Given the angle the sheath created with the lumen of the ivc, one may have predicted the filter to demonstrate tilt once deployed. This is most often encountered from a left femoral venous approach, and there have been publications describing different techniques to minimize this tilt due to the angulation of the iliac vein and ivc. Filter tilt is a known risk in relation to filter implant reported in the published scientific literature. Filter tilt may happen during placement or during implanting period. The perforation was noted at the retrieval procedure. 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. 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. Difficult filter retrieval due to embedment of filter legs or filter hook in the ivc wall is a well-known risk reported in the published scientific literature. Several case reports published in articles, describe successful endovascular retrievals of such filters by advanced retrieval techniques. The root cause for the tilted filter is most likely due to the angle the sheath created with the lumen of the ivc and the root cause for the difficult retrieval is most likely due to the tilted filter with the filter hook abutting the ivc wall. An exact root cause for the perforation cannot be determined based on the patient/event info or the imaging. However, the penetration of this primary filter leg was likely, at least in part, due to the leftward angulation of the entire filter, resulting in abnormal forces placed on this primary filter leg 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 study: during the index procedure on (b)(6) 2016, the patient received a celect® filter. The inferior vena cava (ivc) diameter at the intended filter location was 28 mm. There was no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement. Using the right common femoral vein as the access site, a celect® filter was deployed at the intended location in the ivc infrarenal site and in a location suitable to provide sufficient mechanical protection against pe. The filter neither deployed prematurely nor did the filter jump upon deployment. There was no evidence of filter fracture, deformation, or migration. Filter tilt was 11-< 16 degrees. There was no extravasation of contrast or filter legs appearing outside the column of contrast after filter placement. Analysis of the placement procedure venacavagram revealed no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement. The filter was placed in the ivc infrarenal site and the ivc diameter was 23. 4 mm. There was no evidence of filter migration, extravasation of contrast, or deformation. Filter legs did appear outside the column of contrast after filter placement. The angle of filter tilt in the ap view was 14. 3 degrees. On (b)(6) 2016 (68 days post-procedure), the filter removal was attempted because it was no longer clinically needed. The amount of thrombus present in the filter has not been provided yet. Filter legs did appear outside the column of contrast before retrieval. Retrieval was attempted with a gunther tulip retrieval set via the right internal jugular vein. Additional methods/devices included a right common femoral vein access with wire snare and balloon dilatation to displace filter tip. The physician reported major difficulty retrieving the ivc filter. The filter was not successfully retrieved for the following reasons: hook oriented towards vessel wall; hook embedded in vessel wall and unable to grasp. Patient outcome: the patient was discharged on (b)(6) 2016. The patient remains in the study.
 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN UNISET 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 Key5938421
MDR Text Key54273666
Report Number3002808486-2016-01037
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-2-UNI-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 Received08/19/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/04/2016
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: 09/09/2016 Patient Sequence Number: 1
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