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 Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturers ref# (b)(4).510(k): k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: a (b)(6) male patient underwent an initial placement procedure for an ivc vena cava filter, g34309.The physician pressed the button to release the filter.When attempting to pull the delivery catheter out, the filter also wanted to come out despite a 1cm gap between the delivery catheter and filter.The device was manipulated by moving it forward and backward in attempt to release the filter.On one of the movements forward the physician felt a pop and the filter deployed.There was no migration or tilting; the graft landed where the physician wanted it.Patient outcome: the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the investigation is based on a review of the imaging provided.It was reported that the filter was difficult to release; the filter moved, when attempting to withdraw the delivery system.However, the filter was placed where wanted with no harm to the patient reported.Five fluoroscopic images demonstrate a celect platinum ivc filter in the appropriate anatomic location without evidence of significant tilt, both relative to the bony landmarks.The filter was placed via a jugular approach with the filter introducer and deployment sheath located approximately 2.5 mm cranial to the hook of the ivc filter and proximally 2 mm towards the left side of the hook of the ivc filter.As detailed in the complaint report, attempting to retract the delivery catheter resulted in "the filter also wanted to come out" despite the images clearly demonstrating the grasping hook not in contact with the retrieval hook of the ivc filter.What likely occurred is the grasping hook has inadvertently engaged with the wall of the ivc.With the pulling motion of the filter introducer during attempted removal, this in turn moved the wall of the ivc cranially, and therefore displacing the ivc filter in a similar manner.The complaint report described manipulation of the filter introducer device with and without depressing the release button exposing the grasping hook."on one of the movements forward the physician felt a pop and the filter deployed." this statement likely is in reference to the sensation of the grasping hook becoming detached from the wall of the ivc, and not actually from the ivc filter.The sheath and the filter introducer device were removed at that point without incident and the filter remained in stable appropriate position, although a final image demonstrating this was not submitted for review.The preimplantation venogram was also not submitted for review.If the ivc was angled, collapsed to hypovolemia or of a small diameter, this would facilitated the inadvertent engagement of the grasping hook with the wall.Typically, the filter introducer is centered within the ivc due to slight back tension on the deployment system, and the grasping hook is not long enough to engage with the wall of the ivc in a normal caliber ivc.The ifu states slight back tension should be applied to the introducer prior to pressing the release button, to facilitate straightening of the system and help prevent the grasping hook from coming in contact with the wall of the ivc.In addition, the grasping has a slight bend away from the free margin of the hook which is also designed to direct the hook opening away from the wall of the ivc when the release button is depressed.However, the ivc is extremely compliant, and depending on the size of the ivc and patient's volume status, the wall of the ivc may still come in contact with the grasping hook when it is exposed.In addition, the complaint report does not specify if the deploying physician applied appropriate back tension to the filter during deployment to help mitigate this risk.Fortunately, as the physician did, if the grasping hook is engaged with the wall of the ivc, pressing the release button and moving the filter introducer caudally well facilitate unhooking of the wall of the ivc.In addition, per the report, the ivc filter remained in stable position after successfully removing the deployment sheath and introducer device.The device history record was reviewed with no evidence to suggest that the device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• MDR Report Key: 8934213
• MDR Text Key: 158206784
• Report Number: 3002808486-2019-01307
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)220425(10)E3846246
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2022
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E3846246
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR