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

Catalog Number IGTCFS-65-1-FEM-CELECT-PT

Device Problems Occlusion Within Device (1423); Malposition of Device (2616)

Patient Problems Thrombus (2101); No Consequences Or Impact To Patient (2199)

Event Date 07/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Model and lot #) igtcfs-65-1-fem-celect-pt. Investigation is still in progress.

Event Description

Description of event according to study: on (b)(6) 2015: the inferior vena cava (ivc) diameter at the intended filter location was 24. 0 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 # e3342374) 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, or migration. There was no extravasation of contrast or filter leg(s) appearing outside the column of contrast after filter placement. From the venacavagram, the angle of filter tilt was >
=
16 degrees site report of tilt per post-procedure x-ray ((b)(6) 2015) was 0 degrees. Analysis of the placement procedure venacavagram revealed suboptimal image, unable to provide measurements. There was no ivc anatomic anomaly. Presence of thrombus in the ivc prior to filter placement was unable to be determined. There was thrombus present in the pelvic veins on the right side. The filter placement site was the infrarenal. There was no evidence extravasation of contrast, or deformation. Filter leg(s) did appear outside the column of contrast after filter placement. From the venacavagram, the angle of filter tilt in the ap view was 1. 7 degrees. Comments "occluded right femoral vein". Patient outcome: the patient remains in the clinical study.

Manufacturer Narrative

Manufacturer ref# (b)(4). Igtcfs-65-1-fem-celect-pt. (b)(4). Summary of investigational findings: insignificant tilt is noted on the imaging. 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 root cause for the tilt cannot be determined based on the available information. 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: on (b)(6) 2015: the inferior vena cava (ivc) diameter at the intended filter location was 24. 0 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 # e3342374) 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, or migration. There was no extravasation of contrast or filter leg(s) appearing outside the column of contrast after filter placement. From the venacavagram, the angle of filter tilt was >
=
16 degrees. Site report of tilt per post-procedure x-ray ((b)(6) 2015) was 0 degrees. Analysis of the placement procedure venacavagram revealed suboptimal image, unable to provide measurements. There was no ivc anatomic anomaly. Presence of thrombus in the ivc prior to filter placement was unable to be determined. There was thrombus present in the pelvic veins on the right side. The filter placement site was the infrarenal. There was no evidence extravasation of contrast, or deformation. Filter leg(s) did appear outside the column of contrast after filter placement. From the venacavagram, the angle of filter tilt in the ap view was 1. 7 degrees. Comments "included right femoral vein". Patient outcome: the patient remains in the clinical study.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK 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 Key: 5696739
• MDR Text Key: 47747775
• Report Number: 3002808486-2016-00400
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/24/2015
• 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: 06/03/2016 Patient Sequence Number: 1