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

Catalog Number IGTCFS-65-2-UNI-CELECT-PT

Device Problems Difficult to Remove (1528); Activation Failure (3270)

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

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device under pma/510(k): k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: physician had a procedure dvt case and he inserted jugular entry way filter.The procedure went well and he pressed safety button and next black button.The filter had been mounted on the lesion.Next he tried to remove the filter catheter, but he could not remove the filter catheter.He tried to remove all products (sheath, jugular catheter), but he could not remove.He felt filter had not perfectly deployed.He pressed black button again although sheath, catheter can not be removed.He felt filter and catheter connected, so he pulled the product out by force.Finally first catheter was removed, next sheath was removed patient outcome: no patient adverse effects.

Manufacturer Narrative

Manufacturer ref#: (b(4).Summary of investigational findings: the investigation is based on the event description and the returned device.The jugular introducer with protection sheath and the femoral introducer were returned with the introducer dilator, the introducer sheath, and the stop cock.The introducers, the dilator, and the sheath were all curved, likely to fit into a shipping bag for return to investigation.The sheath was kinked 50.5cm from the distal tip.The grasping hook on the jugular introducer was straightened and this likely occurred when "the product was pulled out by force".The cine video provided demonstrates a celect platinum ivc filter, post deployment, immediately adjacent to the tip of the deployment sheath via a jugular approach without evidence of significant tilt in the infra renal location.With attempted retraction of the filter introducer, there is cranial movement of the ivc filter although the grasping hook is clearly not attached to the hook of the ivc filter.The filter introducer is retracted into the deployment sheath and the filter is seen to be displaced cranially even further.Eventually, it appears that the filter introducer gives way and the forward pressure applied on the introducer sheath result in caudal displacement of the sheath tip running into the ivc filter.As the introducer sheath is withdrawn the ivc filter returns to an appropriate configuration.Despite the filter movement mirroring that of the retracting filter introducer, the grasping hook is not seen extending outside of the filter introducer and is no longer attached to the filter retrieval hook.What has likely occurred is the grasping hook has inadvertently engaged with the wall of the ivc.When the filter introducer is retracted into the sheath, this is pulling the wall of the ivc cranially and therefore displacing the ivc filter with this motion.Eventually, enough force was applied to the filter introducer causing the grasping hook to either tear through the wall of the ivc or release the snared tissue.When this occurs, it happens rather abruptly, resulting in the downward force of the delivery sheath displacing the filter momentarily.The entire system was then retracted cranially in the ivc and the filter returns to its original position.The preimplantation venogram was not submitted for review, however, if the ivc was angled such that the filter introducer was directed towards the wall of the ivc, or it the ivc was of small diameter and/or patient was volume depleted resulting in collapse of the compliant ivc, are all anatomic issues that could have facilitated the inadvertent engagement of the grasping hook with the wall.Typically, the filter introducer is centered within the ivc with slight back tension on the delivery system and the grasping hook is not long enough to engage with the wall of a normal sized ivc.The ifu explicitly states slight back tension should be applied to the introducer prior depressing the release button.This back tension would help straighten and center the system, preventing the grasping hook from coming in contact with the wall of the ivc.The grasping hook has a slight bend away from the free margin of the hook which is also designed this way to direct the hook opening away from the wall of the ivc when the release button is depressed.The complaint report does not specify if the deploying physician applied this back tension to the filter during deployment.Once the grasping hook as engaged with the wall of the ivc, typically pressing the release button and advancing the entire system caudally by a millimeter or two will disengage the hook from the ivc wall and allow the entire system to be removed without difficulty.Fortunately, in this case, manually pulling the filter introducer cranially eventually resulted in the grasping hook detaching from the wall of the ivc and the entire system was removed without apparent incident or complication.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 UNISET 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: 8892345
• MDR Text Key: 158694985
• Report Number: 3002808486-2019-01186
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)220515(10)E3853562
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2022
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT-PT
• Device Lot Number: E3853562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1