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 Problem Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still in progress.

Event Description

Description of event according to study: (b)(6): analysis reported filter tilt =16 degrees post-procedure x-ray.At 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 20.0 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 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 reported as <6 degrees by site.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 evidence of filter deformation or migration with filter tilt of 1.9 degrees in the ap view.There was no extravasation of contrast but filter legs did appear outside the column of contrast after placement.On (b)(6) 2016 (day of procedure), the post-procedure x-ray was completed which revealed filter tilt of <6 degrees by site.Analysis revealed no filter fracture, deformation, or embolization.There was 12.9 degrees filter tilt in the ap view and 23.7 degrees of filter tilt in the oblique view.Patient outcome: the patient remains in the study.

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-1-fem-celect-pt.(b)(4).Summary of investigational findings: investigation is based on description of event and review of provided imaging.The imaging review did not confirm the reported filter tilt of =16deg in reference to the longitudinal axis - the imaging review found significant tilt of 16deg in reference to the spinous processes.Tilt should be measured in reference to the longitudinal axis of the ivc.In this case, the ivc likely does not mirror the course of the anterior margins of the vertebral bodies, (due to may-thurner type anatomy and mild levoconvex curvature of the spine), making the measured tilt a gross overestimation.However since no cross sectional imaging was provided for review the degree of true tilt in reference to the longitudinal axis of the ivc cannot be confirmed.Futhermore, the imaging review measured the maximal diameter in ivc to 10.1 mm and the maximal distance between the primary filter feet is 12mm, which according to the ifu are contraindications for placing a filter.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.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: (b)(6): analysis reported filter tilt =16 degrees post-procedure x-ray.At 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 20.0 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 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 reported as <6 degrees by site.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 evidence of filter deformation or migration with filter tilt of 1.9 degrees in the ap view.There was no extravasation of contrast but filter legs did appear outside the column of contrast after placement.On (b)(6) 2016 (day of procedure), the post-procedure x-ray was completed which revealed filter tilt of <6 degrees by site.Analysis revealed no filter fracture, deformation, or embolization.There was 12.9 degrees filter tilt in the ap view and 23.7 degrees of filter tilt in the oblique view.Patient outcome: the patient remains in the 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: 6134160
• MDR Text Key: 61086919
• Report Number: 3002808486-2016-01457
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)190707(10)E3470197
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2016
• Date Device Manufactured: 07/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 66