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

Model Number G34505

Device Problems Occlusion Within Device (1423); Appropriate Term/Code Not Available (3191)

Patient Problems Thrombosis (2100); Perforation of Vessels (2135)

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-1-uni-celect-pt.Investigation is still in progress.

Event Description

Description of event according to study: (b)(6): filter deformation, grade 2, pe/dvt ¿probably¿ r/t study device.On (b)(6) 2016, the patient had a celect® filter placed.The inferior vena cava (ivc) diameter at the intended filter location was 21.5 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 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 extravasations 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 21.1 mm.There was no evidence of filter migration, extravasations of contrast, or deformation.Filter legs did not appear outside the column of contrast after filter placement.The angle of filter tilt in the ap view was 0.6 degrees.On the same day, the post-procedure x-ray was completed and revealed no evidence of filter fracture, embolization, tilt, or migration.Analysis of the post-procedure x-ray reported no fracture, deformation, or embolization.Migration was not assessed.The angle of filter tilt in ap view was 1.7 degrees and 13.4 degrees in the lat view.On (b)(6) 2017 (100 days post-procedure), the three-month follow-up clinical assessment was performed and a filter retrieval procedure was to be scheduled.On (b)(6) 2017 (112 days post-procedure), the patient underwent a ct of the chest and abdomen with intravenous contrast and it revealed evidence of a pe and thrombus in the ivc and left pelvic veins.There was no evidence of filter fracture, deformation, embolization, or migration.Filter tilt was < 6 degrees.There was a grade 2 filter leg interaction with the ivc wall.The investigator evaluated this event and determined that the pe was possibly related to the study device.Analysis revealed evidence of pe and a thrombus in the ivc within, cranial, and caudal to the filter.There was no evidence of filter fracture, embolization, or migration.The filter had evidence of deformation and bending of the filter.The angle of filter tilt in the sagittal plane was 8 degrees and 4 degrees in the coronal plane.There were 11 filter legs with a grade 1 interaction with ivc wall and one filter leg with grade 2 interaction.The grade 2 interaction had no hemorrhage, hematoma, or other clinical findings observed at the perforation/puncture site.Analysis commented: ¿bilateral pe with saddle.I believe there is ivc thrombus and occlusion, but this is not definitive as the ct was performed in the arterial phase (this may simply reflect unopacified blood).Ivc occlusion would be obvious clinically.One of the filter struts is bent.¿ on (b)(6) 2017 (114 days post-procedure), the patient underwent an ultrasound of the lower extremity which revealed evidence of a dvt in the right lower extremity veins.The investigator evaluated this event and determined that the dvt was possibly related to the study device.Analysis concurred with the site¿s assessment.Patient outcome: the patient remains in the study.

Manufacturer Narrative

Exemption number e2016032.William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on description of event and review of provided imaging.According to the description of event, the patient suffered af pe/dvt, a grade 2 perforation and filter deformation (discovered on 112 days post-procedure imaging).Imaging from time of placement demonstrated no tilt and no perforation.Imaging review confirms pe/dvt, grade 2 perforation of ivc wall and filter deformation of a secondary filter leg.A ct scan demonstrated a large amount of pe, which given the overall size and configuration suggest a thrombus originating from the lower extremities.The ct scan also demonstrated a 110 deg bent of a secondary leg placing its tip cranial to the filter hook.This secondary leg demonstrates a grade 2 interaction with the ivc wall.The deformed secondary filter leg is likely to have contributed to the pe.However, it is very unusual for a single leg to be so significantly deformed suggesting a device (either injecting catheter from filter placement or a guidewire from following surgery) going through or adjacent to the ivc filter.Pe is a known risk in relation to filter implant reported in the published scientific literature.Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins.With all filters, there is some risk of further pulmonary embolism.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.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 6390672
• MDR Text Key: 69444603
• Report Number: 3002808486-2017-00764
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)190822(10)E3485317
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/27/2017
• Device Age: 6 MO
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/09/2017
• Supplement Dates Manufacturer Received: 03/01/2017
• Supplement Dates FDA Received: 08/10/2017
• Date Device Manufactured: 08/22/2016
• 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: 61 YR
• Patient Weight: 143