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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G34309
Device Problems Occlusion Within Device (1423); Malposition of Device (2616); Positioning Problem (3009); Appropriate Term/Code Not Available (3191)
Patient Problems Internal Organ Perforation (1987); Thrombosis (2100); Perforation of Vessels (2135); No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2016
Event Type  Injury  
Manufacturer Narrative
Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). Summary of investigational findings: investigation is based on the event description and imaging review. Approx. 17 months after filter placement there is interval development of five grade 2 interactions with the wall of the ivc. The filter has also been displaced caudally by approximately17 mm, with no significant tilt. The grade 2 interactions, as well as the caudal displacement of the filter, are related to the remodeling of the chronically occluded ivc and iliac veins. As the thrombosis evolved, the diameter of the ivc decreased and overall length of the vein shortened. The new pulmonary embolism, in the setting of the ivc filter, indicates recurrent pulmonary embolism by definition. However, this case is not a result of the filter¿s inability to capture the clot, but rather due to the dislodgment of clot that was located cranial to the ivc filter as seen on multiple prior ct scans and venograms. Also, approx. 22 months after filter placement the ivc appears atretic and is completely collapsed around the inferior vena cava filter resulting in compression of the primary and secondary legs as well as retraction of the ivc filter, causing caudal displacement of the ivc, relative to the bony landmarks. However, the filter did not truly move relative to the ivc, rather the entire ivc moved relative to the bony landmarks as it contracted. Given the inability to perceive the wall of the inferior vena cava on many of these images, evaluation for degrees of penetration is difficult. All the primary and secondary legs appear to demonstrate grade 1 interactions with the wall of the ivc, but there may indeed be persistent grade 2 interactions present. The initial cause of ivc filter thrombosis is indeterminate, but the presence of an ivc filter does increase the risk of caval and lower extremity thrombosis. The caval thrombosis contributed to the development of recurrent pulmonary emboli, grade 2 interactions with the wall of the ivc as well as the caudal filter movement. Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature. Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound, ct, mr imaging or venography; this may be symptomatic or asymptomatic. 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. 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.
 
Manufacturer Narrative
(b)(4). Catalog # igtcfs-65-1-jug-celect. Investigation is still in progress.
 
Event Description
Description of event according to study: the inferior vena cava (ivc) diameter at the intended filter location was 21. 24 mm. There was no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement. Using the right internal jugular vein as the access site, a celect® filter (lot # e3387008) was deployed at the intended location in the ivc infrarenal site and in a location suitable to provide sufficient mechanical protection against pulmonary embolism (pe). The filter neither deployed prematurely nor did the filter jump upon deployment. There was no evidence of filter fracture, deformation, tilt, or migration. There was no extravasation of contrast and filter legs did appear 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 at the filter location was not assessed due to insufficient contrast and no fiduciary or marking catheter used. There was no evidence of filter migration, extravasation of contrast, or deformation. Filter legs appearing outside the column of contrast after filter placement was not assessed. The angle of filter tilt in the ap view was one degree. On (b)(6) 2016, unscheduled imaging (82 days post-procedure): site: grade 1 filter leg interaction with ivc wall. Patient outcome: the patient remains in the clinical study.
 
Manufacturer Narrative
(b)(4). Catalog#: igtcfs-65-1-jug-celect. Investigation is still in progress.
 
Event Description
Description of event according to study: the inferior vena cava (ivc) diameter at the intended filter location was 21. 24 mm. There was no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement. Using the right internal jugular vein as the access site, a celect® filter (lot # e3387008) was deployed at the intended location in the ivc infrarenal site and in a location suitable to provide sufficient mechanical protection against pulmonary embolism (pe). The filter neither deployed prematurely nor did the filter jump upon deployment. There was no evidence of filter fracture, deformation, tilt, or migration. There was no extravasation of contrast and filter legs did appear 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 at the filter location was not assessed due to insufficient contrast and no fiduciary or marking catheter used. There was no evidence of filter migration, extravasation of contrast, or deformation. Filter legs appearing outside the column of contrast after filter placement was not assessed. The angle of filter tilt in the ap view was one degree. On (b)(6) 2016, unscheduled imaging (82 days post-procedure): site: grade 1 filter leg interaction with ivc wall. Additional information received on 06jul2016: on (b)(6) 2016, unscheduled imaging (82 days post-procedure): site: filter tilt: 11-<16. Number of leg interactions with ivc wall grade 1: 1. Analysis: filter tilt: 16 degrees in coronal plane. Number of leg interactions with ivc wall grade 1: 6. Patient outcome: the patient remains in the clinical study.
 
Manufacturer Narrative
(b)(4). Igtcfs-65-1-jug-celect. (b)(4). Summary of investigational findings: follow-up ct scan demonstrates: no evidence of grade 1 interaction between the filter and the wall of the ivc. Insignificant, 9°, of leftward tilt. Near complete resolution of the pulmonary embolic burden. Complete thrombosis of the inferior vena cava, bilateral iliac veins, bilateral common femoral veins, and portions of bilateral superficial femoral veins. There was also thrombus extending above the level of the filter. The complaint report makes no note of the extensive ivc thrombosis. Filter perforation is a known risk in relation to filter implant reported in the published scientific literature. Image review did not confirm the reported grade 1 filter leg interaction with the ivc wall. 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. The complaint report does not discuss whether patient was currently anticoagulated at time of ivc thrombosis and or the timeframe associated with the symptoms. The complaint report makes no note of the interventions to follow to treat the extensive thrombosis. Based on the investigation, it is not possible to determine the root cause of this event. There is 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. 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: the inferior vena cava (ivc) diameter at the intended filter location was 21. 24 mm. There was no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement. Using the right internal jugular vein as the access site, a celect filter (lot # e3387008) was deployed at the intended location in the ivc infrarenal site and in a location suitable to provide sufficient mechanical protection against pulmonary embolism (pe). The filter neither deployed prematurely nor did the filter jump upon deployment. There was no evidence of filter fracture, deformation, tilt, or migration. There was no extravasation of contrast and filter legs did appear 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 at the filter location was not assessed due to insufficient contrast and no fiduciary or marking catheter used. There was no evidence of filter migration, extravasation of contrast, or deformation. Filter legs appearing outside the column of contrast after filter placement was not assessed. The angle of filter tilt in the ap view was one degree. On (b)(6) 2016, unscheduled imaging (82 days post-procedure): site: grade 1 filter leg interaction with ivc wall. Additional information received on 06jul2016: on (b)(6) 2016, unscheduled imaging (82 days post-procedure): site: filter tilt: 11-<16. Number of leg interactions with ivc wall grade 1: 1. Analysis: filter tilt: 16 degrees in coronal plane. Number of leg interactions with ivc wall grade 1: 6. Patient outcome: the patient remains in the clinical study.
 
Manufacturer Narrative
(b)(4). Catalog #: igtcfs-65-1-jug-celect-pt. (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to study: the inferior vena cava (ivc) diameter at the intended filter location was 21. 24 mm. There was no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement. Using the right internal jugular vein as the access site, a celect® filter (lot # e3387008) was deployed at the intended location in the ivc infrarenal site and in a location suitable to provide sufficient mechanical protection against pulmonary embolism (pe). The filter neither deployed prematurely nor did the filter jump upon deployment. There was no evidence of filter fracture, deformation, tilt, or migration. There was no extravasation of contrast and filter legs did appear 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 at the filter location was not assessed due to insufficient contrast and no fiduciary or marking catheter used. There was no evidence of filter migration, extravasation of contrast, or deformation. Filter legs appearing outside the column of contrast after filter placement was not assessed. The angle of filter tilt in the ap view was one degree. On (b)(6) 2016, unscheduled imaging (82 days post-procedure): site: grade 1 filter leg interaction with ivc wall. Additional information received on 06jul2016: on (b)(6) 2016, unscheduled imaging (82 days post-procedure): site: filter tilt: 11-<16. Number of leg interactions with ivc wall grade 1: 1. Analysis: filter tilt: 16 degrees in coronal plane. Number of leg interactions with ivc wall grade 1: 6. Additional information received 15mar2017: on (b)(6) 2016 (31 days post-procedure), the post placement x-ray was performed. There was no evidence of filter fracture, embolization, tilt, or migration. Analysis revealed no evidence of filter fracture, deformation, or embolization. Migration was not assessed. The angle of filter tilt in the ap view was 1. 3 degrees and 2. 2 degrees in the oblique view. On (b)(6) 2016 (329 days post-procedure), the 12-month ct was performed. The ct of the abdomen and pelvis revealed no evidence of filter embolization. There was a grade 2 filter leg interaction with the ivc wall. Analysis revealed no evidence of embolization. The angle of filter tilt in the sagittal plane was 0. 8 degrees and 4. 7 degrees in the coronal plane. There were twelve grade 1 filter legs. On (b)(6) 2017 (366 days post-procedure), the 12-month clinical assessment, ultrasound, and x-ray was performed. The filter was not scheduled to be retrieved due to an ongoing risk for pe and a poor overall health/prognosis. The patient was not taking antiplatelet or anticoagulant medications. The ultrasound revealed evidence of thrombus in the bilateral lower extremity veins. The ivc and pelvic veins were not assessed. Analysis revealed evidence of thrombus in the left lower extremity. The ivc, pelvic veins, and right lower extremity was not assessed. The x-ray revealed no evidence of filter fracture, embolization, tilt, or migration. Analysis revealed no evidence of filter fracture, deformation, or embolization. A 29 mm caudal migration of the filter was present. The angle of filter tilt in the ap view was 9. 2 degrees and 3 degrees in the lat view. Patient outcome: the patient remains in the clinical study.
 
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Brand NameCOOK CELECT PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key5700237
MDR Text Key248324421
Report Number3002808486-2016-00424
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 study
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberG34309
Device Catalogue NumberIGTCFS-65-1-JUG-CELECT-PT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/13/2016
Device Age5 MO
Event Location No Information
Date Manufacturer Received07/08/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/16/2015
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: 06/06/2016 Patient Sequence Number: 1
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