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

Model Number G34309

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Perforation of Vessels (2135)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-1-jug-celect-pt.Name and address for importer site: (b)(4).Investigation is still in progress.

Event Description

Description of event according to study: on (b)(6) 2016, the patient received a celect® filter.The primary reason for filter placement was no venous thromboembolism (vte) present, but at risk for vte due to a prior history of vte and surgery.The patient did not have a contraindication to anticoagulation.The inferior vena cava (ivc) diameter at the intended filter location was 22.52 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, or migration.There was no extravasation of contrast or filter leg(s) appearing outside the column of contrast after filter placement.The angle of filter tilt was < 6 degrees.On the post-procedure x-ray ((b)(6) 2016), the site reported no evidence of filter fracture, embolization, or migration.Filter tilt was < 6 degrees.On (b)(6) 2017, the 12-month ct of the abdomen and pelvis was completed.There was no evidence of filter embolization and a grade 2 filter leg interaction with the ivc wall.On (b)(6) 2017, the 12-month follow-up clinical assessment and ultrasound were completed.Filter retrieval was not scheduled due to a contraindication to anticoagulation.The ultrasound revealed no evidence of thrombus in the ivc, pelvic veins, or lower extremities.Patient outcome: the patient remains in the study.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Manufacturer ref# (b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on event description and image review.Venogram at time of ivc filter placement demonstrates appropriate placement of a celect-pt filter in the infrarenal location without evidence of significant tilt or immediate penetration.Ct scan approximately 12 months after implantation demonstrates the celect-pt filter in relatively stable position.There is no evidence of significant tilt, relative to the central line of the ivc, however, there was development of a grade 2 filter leg interaction with the wall of the ivc.There is no comment within the complaint report regarding any potential symptoms attributable to this penetration.Another follow-up ultrasound approx.5 months later demonstrates the celect-pt filter in stable craniocaudal position, but on the lateral projection, there was development of 16° of anterior tilt relative to the anterior margins of the vertebral bodies.When compared to the sagittal images from the ct scan obtained on (b)(6) 2017, there is an intrinsic divergent course of the ivc relative to the anterior margins of the vertebral bodies, at the level of the l2/l3 vertebral body measuring approximately 11°.Therefore, the measured tilt relative to the bony landmarks was an overestimation by 11° and the true anterior tilt of the ivc filter measures only 5°, which would be defined as insignificant.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 wil continue to monitor for similar events.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN JUGULAR 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: 7120340
• MDR Text Key: 94931121
• Report Number: 3002808486-2017-02496
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)190531(10)E3455582
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/01/2017
• Device Age: 15 MO
• Date Manufacturer Received: 03/05/2018
• Date Device Manufactured: 05/31/2016
• 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: 53 YR
• Patient Weight: 127