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U.S. Department of Health and Human Services

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

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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 Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
Patient Problems Pulmonary Edema (2020); Renal Disease, End Stage (2039); Chronic Obstructive Pulmonary Disease (COPD) (2237)
Event Date 07/07/2015
Event Type  Injury  
Manufacturer Narrative
Manufacturer ref# (b)(4). Model #: igtcfs-65-1-fem-celect-pt. Investigation is still in progress.
 
Event Description
Description of event according to study: on (b)(6) 2015 (one day pre-procedure), the pre-placement ultrasound was completed. There was no evidence of thrombus in the lower extremity veins. Analysis of the pre-placement ultrasound showed no evidence of thrombus in the pelvic veins or lower extremity veins. There was no evidence of pulmonary embolism prior to the procedure. The primary reason for the filter placement was no venous thromboembolism (vte) present but at risk for vte due to a prior history of vte and profound anemia. The filter placement was anticipated to be temporary and was accomplished with the use of a venacavagram. The ivc diameter at the intended filter location was 19. 7 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 (lot# e3309428) was deployed at the intended location in the ivc infrarenal site and in a location suitable to provide sufficient mechanical protection against pulmonary embolism. The filter neither deployed prematurely nor did the filter jump upon deployment. There was no evidence of filter tilt, fracture, deformation, or migration. There was no extravasation of contrast, and no filter legs appeared outside the column of contrast after filter placement. Filter tilt was
=
16 degrees. Analysis of the placement procedure venacavagram indicated no ivc anatomic anomaly or presence of thrombus. The presence of thrombus was not assessed in the pelvic or lower extremity veins. The filter was placed in the ivc infrarenal site. The ivc diameter at the filter location was not assessed. There was no evidence of filter deformation, migration, extravasation of contrast, or filter legs appearing outside the column of contrast after filter placement. Filter tilt in the ap view was 10. 8 degrees. On (b)(6) 2015 (day of procedure), the post-procedure x-ray was performed and revealed no evidence of filter fracture, embolization, or migration. The angle of tilt was 6-11 degrees. Analysis of the post-procedure x-ray revealed no evidence of filter fracture, deformation, embolization, or migration. The angle of tilt in the ap view was 4 degrees. The angle of tilt in the lat view was 7. 9 degrees. On (b)(6) 2015 (27 days post-procedure), an x-ray was performed, which was associated with clinical sequelae and led to treatment. The patient was diagnosed with exacerbation of copd and pulmonary edema. The investigative site noted that the patient has end-stage renal disease requiring dialysis and the event was caused by non-compliance with appropriate diet and medical treatment. The patient was treated with hemodialysis an dbipap. The filter was not assessed. On 09jun2016 additional information: post-procedure x-ray ((b)(6) 2015) for filter tilt revealed: site:
=
11 degrees. Analysis: 4 degrees in ap view, 7. 9 degrees in lat view. Pre-retrieval x-ray ((b)(6) 2015) for filter tilt revealed: site: 0 tilt. Analysis: 1. 7 degrees in ap view, 6. 9 degrees in lat view. On 09jun2016 additional information: on (b)(6) 2015 (101 days post-procedure), the filter was no longer clinically indicated and was retrieved. On (b)(6) 2015 (127 days post-procedure), the patient completed the study follow-up and exited the study. Patient outcome: the patient was discharged from the hospital on (b)(6) 2015 (30 days post-procedure).
 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer Contact
marianne hoey
sandet 6
bjaeverskov 4632
DA   4632
56868686
MDR Report Key5722311
MDR Text Key47291951
Report Number3002808486-2016-00546
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation
Type of Report Initial
Report Date 07/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
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 Received07/09/2015
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/05/2015
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: 06/14/2016 Patient Sequence Number: 1
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