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

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

Device Problems Bent (1059); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2016

Event Type  malfunction  

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; on (b)(6) 2016, during the index procedure the patient had a celect® filter placed.The inferior vena cava (ivc) diameter at the intended filter location was 18.0 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 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 < 6 degrees.There was no extravasation of contrast and no filter legs appeared 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 20.4 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 4.2 degrees.On the same day, the post-procedure x-ray was completed and revealed no evidence of filter fracture, embolization or migration.Filter tilt was 6 -< 11 degrees.Analysis of the post-procedure x-ray reported no fracture, deformation, or embolization.Migration was not assessed.Filter tilt of 2.4 degrees in ap view and 4.5 degrees in the lat view.On (b)(6) 2016 (64 days post-procedure), the pre-retrieval procedure x-ray was completed and site indicated no fracture, embolization or migration, with a filter tilt of 6 -< 11 degrees.The filter was no longer clinically indicated and was retrieved endovascularly with minimal difficulty.Analysis of the pre-retrieval procedure x-ray revealed no evidence of filter fracture, embolization or migration.Filter tilt of 3.5 degrees in ap view and 1.2 degrees in the lat view.Filter deformation was reported: bending of the filter (analysis comment: ¿lateral right struts are bent or bowed¿).Patient outcome: the ivc filter was removed endovascularly without problems.The patient remains in the study.

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog#: igtcfs-65-1-jug-celect-pt.Summary of investigational findings: the celect-pt filter was placed in ivc with insignificant 11° leftward tilt prior to planned surgery.During filter retrieval approx.2 months later it was noted that the two right lateral most secondary legs had perforated the ivc by approx.4mm and 12 mm, respectively.This change in position is likely attributed to the original tilt described and may be the reported "filter deformation", as the penetrated legs appear displaced cranially in reference to he original orientation.It is noted that the filter was retrieved with minimal difficulty.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.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) 2016: during the index procedure the patient had a celect® filter placed.The inferior vena cava (ivc) diameter at the intended filter location was 18.0 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 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 < 6 degrees.There was no extravasation of contrast and no filter legs appeared 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 20.4 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 4.2 degrees.On the same day, the post-procedure x-ray was completed and revealed no evidence of filter fracture, embolization or migration.Filter tilt was 6 -< 11 degrees.Analysis of the post-procedure x-ray reported no fracture, deformation, or embolization.Migration was not assessed.Filter tilt of 2.4 degrees in ap view and 4.5 degrees in the lat view.On (b)(6) 2016: (64 days post-procedure), the pre-retrieval procedure x-ray was completed and site indicated no fracture, embolization or migration, with a filter tilt of 6 -< 11 degrees.The filter was no longer clinically indicated and was retrieved endovascularly with minimal difficulty.Analysis of the pre-retrieval procedure x-ray revealed no evidence of filter fracture, embolization or migration.Filter tilt of 3.5 degrees in ap view and 1.2 degrees in the lat view.Filter deformation was reported: bending of the filter (analysis comment: ¿lateral right struts are bent or bowed¿).Patient outcome: the ivc filter was removed endovascularly without problems.The patient remains in the study.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN JUGULAR 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: 6207984
• MDR Text Key: 63368435
• Report Number: 3002808486-2016-01531
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)190421(10)E3441918
• 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: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Date Device Manufactured: 04/21/2016
• 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: 42 YR
• Patient Weight: 201